Trial Outcomes & Findings for A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer (NCT NCT03703466)
NCT ID: NCT03703466
Last Updated: 2024-04-02
Results Overview
Percentage of participants with severe diarrhea (≥ grade 3) during the first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 was defined as an increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living (ADL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Cycle 3 (28 Days Cycle)
Results posted on
2024-04-02
Participant Flow
Participant milestones
| Measure |
200 mg Abemaciclib With a Meal
200 mg abemaciclib given twice a day (BID) orally with a meal.
|
200 mg Abemaciclib Without a Meal
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
|
Overall Study
Received at Least One Dose of Study Drug
|
24
|
23
|
24
|
|
Overall Study
COMPLETED
|
20
|
18
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
2
|
Reasons for withdrawal
| Measure |
200 mg Abemaciclib With a Meal
200 mg abemaciclib given twice a day (BID) orally with a meal.
|
200 mg Abemaciclib Without a Meal
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
|
Overall Study
Completed < 3 Cycles
|
2
|
2
|
2
|
Baseline Characteristics
A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
200 mg Abemaciclib With a Meal
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally with a meal.
|
200 mg Abemaciclib Without a Meal
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
70 Participants
n=4 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
|
|
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
|
|
Region of Enrollment
Turkey
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Cycle 3 (28 Days Cycle)Population: All participants who received at least one dose of study drug.
Percentage of participants with severe diarrhea (≥ grade 3) during the first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 was defined as an increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living (ADL).
Outcome measures
| Measure |
200 mg Abemaciclib With a Meal
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally with a meal..
|
200 mg Abemaciclib Without a Meal
n=23 Participants
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
Percentage of Participants With Severe Diarrhea (≥ Grade 3)
|
4.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Cycle 3 (28 Days Cycle)Population: All participants who received at least one dose of study drug.
Percentage of participants with prolonged grade 2 diarrhea during first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Prolonged Grade 2 diarrhea was any event lasting more than 7 days. Grade 2 was defined as Increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline.
Outcome measures
| Measure |
200 mg Abemaciclib With a Meal
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally with a meal..
|
200 mg Abemaciclib Without a Meal
n=23 Participants
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
Percentage of Participants With Prolonged Grade 2 Diarrhea
|
8.3 percentage of participants
|
17.4 percentage of participants
|
20.8 percentage of participants
|
PRIMARY outcome
Timeframe: Cycle 3 (28 Days Cycle)Population: All participants who received at least one dose of study drug.
Percentage of participants with dose reductions due to diarrhea during first 3 cycles.
Outcome measures
| Measure |
200 mg Abemaciclib With a Meal
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally with a meal..
|
200 mg Abemaciclib Without a Meal
n=23 Participants
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
Percentage of Participants With Dose Reductions Due to Diarrhea
|
16.7 percentage of participants
|
8.7 percentage of participants
|
12.5 percentage of participants
|
PRIMARY outcome
Timeframe: Cycle 3 (28 Days Cycle)Population: All participants who received at least one dose of study drug.
Percentage of participants with dose interruptions due to diarrhea during first 3 cycles.
Outcome measures
| Measure |
200 mg Abemaciclib With a Meal
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally with a meal..
|
200 mg Abemaciclib Without a Meal
n=23 Participants
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
Percentage of Participants With Dose Interruptions Due to Diarrhea
|
16.7 percentage of participants
|
4.3 percentage of participants
|
8.3 percentage of participants
|
PRIMARY outcome
Timeframe: Cycle 3 (28 Days Cycle)Population: All participants who received at least one dose of study drug.
Percentage of participants who discontinue treatment due to diarrhea
Outcome measures
| Measure |
200 mg Abemaciclib With a Meal
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally with a meal..
|
200 mg Abemaciclib Without a Meal
n=23 Participants
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
Percentage of Participants Who Discontinue Treatment Due to Diarrhea
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Cycle 3 (28 Days Cycle)Population: All participants who received at least one dose of study drug.
Percentage of participants who utilized anti diarrheals at least once during the first 3 cycles.
Outcome measures
| Measure |
200 mg Abemaciclib With a Meal
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally with a meal..
|
200 mg Abemaciclib Without a Meal
n=23 Participants
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
Percentage of Participants Utilizing Antidiarrheals
|
95.8 percentage of participants
|
91.3 percentage of participants
|
95.8 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1: Day 15; Cycle 2: Day 1, Day 15; Cycle 3: Day 1 (28 Days Cycle)Population: All participants who received at least one dose of study drug who had evaluable PK data.
PK: Mean steady state exposure of abemaciclib
Outcome measures
| Measure |
200 mg Abemaciclib With a Meal
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally with a meal..
|
200 mg Abemaciclib Without a Meal
n=21 Participants
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
n=21 Participants
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Cycle 1: Day 15
|
305 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 198
|
369 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 64
|
356 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 75
|
|
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Cycle 2: Day 1
|
320 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 91
|
280 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 99
|
190 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 284
|
|
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Cycle 2: Day 15
|
77.4 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 731
|
345 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
223 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 250
|
|
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Cycle 3: Day 1
|
135 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 896
|
330 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 54
|
85.4 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 498
|
SECONDARY outcome
Timeframe: Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)Population: All participants who received at least one dose of study drug who had evaluable PK data.
PK: Mean steady state exposure of abemaciclib metabolite LSN2839567
Outcome measures
| Measure |
200 mg Abemaciclib With a Meal
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally with a meal..
|
200 mg Abemaciclib Without a Meal
n=21 Participants
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
n=21 Participants
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
Cycle 1 Day 15
|
139 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 109
|
129 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
159 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 61
|
|
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
Cycle 2 Day 1
|
125 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 62
|
109 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 84
|
96.3 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 127
|
|
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
Cycle 2 Day 15
|
50.4 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 276
|
121 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 45
|
112 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 79
|
|
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
Cycle 3 Day 1
|
89.4 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 110
|
125 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
61.7 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 122
|
SECONDARY outcome
Timeframe: Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)Population: All participants who received at least one dose of study drug who had evaluable PK data.
PK: Mean steady state exposure of abemaciclib metabolite LSN3106726
Outcome measures
| Measure |
200 mg Abemaciclib With a Meal
n=24 Participants
200 mg abemaciclib given twice a day (BID) orally with a meal..
|
200 mg Abemaciclib Without a Meal
n=21 Participants
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
n=21 Participants
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
Cycle 1 Day 15
|
231 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 120
|
242 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
287 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 63
|
|
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
Cycle 2 Day 1
|
230 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 59
|
210 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 57
|
152 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 222
|
|
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
Cycle 2 Day 15
|
80.5 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 377
|
221 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
182 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 112
|
|
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
Cycle 3 Day 1
|
146 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 174
|
223 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
107 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 172
|
Adverse Events
200 mg Abemaciclib With a Meal
Serious events: 3 serious events
Other events: 24 other events
Deaths: 3 deaths
200 mg Abemaciclib Without a Meal
Serious events: 5 serious events
Other events: 23 other events
Deaths: 4 deaths
200 mg Abemaciclib Without Regard to Food
Serious events: 8 serious events
Other events: 24 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
200 mg Abemaciclib With a Meal
n=24 participants at risk
200 mg abemaciclib given twice a day (BID) orally with a meal.
|
200 mg Abemaciclib Without a Meal
n=23 participants at risk
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
n=24 participants at risk
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
13.0%
3/23 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Guillain-barre syndrome
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
200 mg Abemaciclib With a Meal
n=24 participants at risk
200 mg abemaciclib given twice a day (BID) orally with a meal.
|
200 mg Abemaciclib Without a Meal
n=23 participants at risk
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
|
200 mg Abemaciclib Without Regard to Food
n=24 participants at risk
200 mg abemaciclib given twice a day (BID) orally without regard for food.
|
|---|---|---|---|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
8.3%
2/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
58.3%
14/24 • Number of events 34 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
47.8%
11/23 • Number of events 19 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
41.7%
10/24 • Number of events 33 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 5 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.3%
2/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
6/24 • Number of events 18 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
34.8%
8/23 • Number of events 21 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
37.5%
9/24 • Number of events 25 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
8.3%
2/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 8 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Eye disorders
Lid sulcus deepened
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 5 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 9 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
41.7%
10/24 • Number of events 12 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
17.4%
4/23 • Number of events 5 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
20.8%
5/24 • Number of events 8 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
2/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Angular cheilitis
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
12.5%
3/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
87.5%
21/24 • Number of events 204 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
95.7%
22/23 • Number of events 187 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
91.7%
22/24 • Number of events 229 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
16.7%
4/24 • Number of events 12 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.5%
3/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mallory-weiss syndrome
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
62.5%
15/24 • Number of events 16 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
47.8%
11/23 • Number of events 21 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
58.3%
14/24 • Number of events 20 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral blood blister
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Retching
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
10/24 • Number of events 23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
43.5%
10/23 • Number of events 20 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
29.2%
7/24 • Number of events 10 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
25.0%
6/24 • Number of events 10 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
21.7%
5/23 • Number of events 12 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
16.7%
4/24 • Number of events 12 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
45.8%
11/24 • Number of events 15 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
17.4%
4/23 • Number of events 5 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
41.7%
10/24 • Number of events 20 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Mucosal dryness
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
12.5%
3/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
20.8%
5/24 • Number of events 6 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Nodule
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
4.2%
1/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic pain
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacterial rhinitis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Covid-19
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Paronychia
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
4.2%
1/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
4/24 • Number of events 6 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
12.5%
3/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
4/24 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
4.2%
1/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
3/24 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
1/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
4/24 • Number of events 7 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
20.8%
5/24 • Number of events 9 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
6/24 • Number of events 11 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
17.4%
4/23 • Number of events 7 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
16.7%
4/24 • Number of events 8 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
2/24 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
16.7%
4/24 • Number of events 8 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
12.5%
3/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
13.0%
3/23 • Number of events 7 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood calcium decreased
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
12.5%
3/24 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
21.7%
5/23 • Number of events 10 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
16.7%
4/24 • Number of events 8 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase decreased
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood phosphorus decreased
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
3/24 • Number of events 5 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
17.4%
4/23 • Number of events 7 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
16.7%
4/24 • Number of events 10 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
20.8%
5/24 • Number of events 19 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
13.0%
3/23 • Number of events 6 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
20.8%
5/24 • Number of events 20 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
29.2%
7/24 • Number of events 35 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
26.1%
6/23 • Number of events 15 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
41.7%
10/24 • Number of events 41 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
45.8%
11/24 • Number of events 34 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
30.4%
7/23 • Number of events 16 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
20.8%
5/24 • Number of events 12 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Protein total decreased
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
21.7%
5/23 • Number of events 7 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
12.5%
3/24 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
37.5%
9/24 • Number of events 31 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
30.4%
7/23 • Number of events 27 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
29.2%
7/24 • Number of events 39 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
8/24 • Number of events 11 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
34.8%
8/23 • Number of events 12 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
37.5%
9/24 • Number of events 11 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.3%
2/24 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
13.0%
3/23 • Number of events 10 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
21.7%
5/23 • Number of events 8 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin b12 deficiency
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
13.0%
3/23 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
16.7%
4/24 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
3/24 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
20.8%
5/24 • Number of events 6 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Brain fog
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
20.8%
5/24 • Number of events 6 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
20.8%
5/24 • Number of events 7 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sensory disturbance
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sleep deficit
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Taste disorder
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depressed mood
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
4/24 • Number of events 5 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
21.7%
5/23 • Number of events 6 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.8%
5/24 • Number of events 5 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
12.5%
3/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
2/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
17.4%
4/23 • Number of events 6 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
12.5%
3/24 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
4/24 • Number of events 4 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.7%
2/23 • Number of events 3 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
8.3%
2/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Abdominal cavity drainage
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
4.2%
1/24 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.3%
1/23 • Number of events 1 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/24 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
0.00%
0/23 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
4.2%
1/24 • Number of events 2 • Baseline until end of the follow-up (Up To 44 months)
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60