Trial Outcomes & Findings for A Study of Abemaciclib in Indian Women With Advanced Breast Cancer (NCT NCT04707196)
NCT ID: NCT04707196
Last Updated: 2023-11-24
Results Overview
Treatment-emergent adverse events (TEAEs) are defined as any adverse events that started at the time of, or after the, first study medication administration as well as those events that started prior to the first study drug administration, but which worsened after the first study medication administration. The reported data reflects the unique percentage of participants who experienced any serious and other non-serious adverse events. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
Baseline until end of follow-up (Up To 7 Months)
Results posted on
2023-11-24
Participant Flow
Participant milestones
| Measure |
Abemaciclib + NSAI
Participants received abemaciclib 150 milligram (mg) orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus NSAI (nonsteroidal aromatase inhibitors - either anastrozole or letrozole) administered orally as per standard of care.
|
Abemaciclib + Fulvestrant
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus fulvestrant administered intramuscularly as per standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
137
|
63
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
137
|
63
|
|
Overall Study
COMPLETED
|
108
|
43
|
|
Overall Study
NOT COMPLETED
|
29
|
20
|
Reasons for withdrawal
| Measure |
Abemaciclib + NSAI
Participants received abemaciclib 150 milligram (mg) orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus NSAI (nonsteroidal aromatase inhibitors - either anastrozole or letrozole) administered orally as per standard of care.
|
Abemaciclib + Fulvestrant
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus fulvestrant administered intramuscularly as per standard of care.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Non-compliance with study drug
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
4
|
1
|
|
Overall Study
Progressive disease
|
9
|
10
|
Baseline Characteristics
A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Abemaciclib + NSAI
n=137 Participants
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus NSAI (nonsteroidal aromatase inhibitors - either anastrozole or letrozole) administered orally as per standard of care.
|
Abemaciclib + Fulvestrant
n=63 Participants
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus Fulvestrant administered intramuscularly as per standard of care.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.60 years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
51.80 years
STANDARD_DEVIATION 12.54 • n=7 Participants
|
54.40 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
137 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
200 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
137 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline until end of follow-up (Up To 7 Months)Population: All participants who received at least one dose of study drug.
Treatment-emergent adverse events (TEAEs) are defined as any adverse events that started at the time of, or after the, first study medication administration as well as those events that started prior to the first study drug administration, but which worsened after the first study medication administration. The reported data reflects the unique percentage of participants who experienced any serious and other non-serious adverse events. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Abemaciclib + NSAI
n=137 Participants
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus NSAI (nonsteroidal aromatase inhibitors - either anastrozole or letrozole) administered orally as per standard of care.
|
Abemaciclib + Fulvestrant
n=63 Participants
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus Fulvestrant administered intramuscularly as per standard of care.
|
|---|---|---|
|
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event
|
78.1 percentage of participants
|
69.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until end of study treatment (Up To 6 Months)Population: All participants who received at least one dose of study drug.
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Abemaciclib + NSAI
n=137 Participants
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus NSAI (nonsteroidal aromatase inhibitors - either anastrozole or letrozole) administered orally as per standard of care.
|
Abemaciclib + Fulvestrant
n=63 Participants
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus Fulvestrant administered intramuscularly as per standard of care.
|
|---|---|---|
|
Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events
|
3.6 percentage of participants
|
4.8 percentage of participants
|
Adverse Events
Abemaciclib + NSAI
Serious events: 9 serious events
Other events: 105 other events
Deaths: 3 deaths
Abemaciclib + Fulvestrant
Serious events: 5 serious events
Other events: 44 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Abemaciclib + NSAI
n=137 participants at risk
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus NSAI (nonsteroidal aromatase inhibitors - either anastrozole or letrozole) administered orally as per standard of care.
|
Abemaciclib + Fulvestrant
n=63 participants at risk
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus Fulvestrant administered intramuscularly as per standard of care.
|
|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
General disorders
Death
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Abemaciclib + NSAI
n=137 participants at risk
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus NSAI (nonsteroidal aromatase inhibitors - either anastrozole or letrozole) administered orally as per standard of care.
|
Abemaciclib + Fulvestrant
n=63 participants at risk
Participants received abemaciclib 150 mg orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus Fulvestrant administered intramuscularly as per standard of care.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.4%
32/137 • Number of events 48 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
22.2%
14/63 • Number of events 22 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.9%
19/137 • Number of events 39 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
9.5%
6/63 • Number of events 13 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.8%
34/137 • Number of events 61 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
17.5%
11/63 • Number of events 22 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.2%
3/137 • Number of events 7 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
6.3%
4/63 • Number of events 16 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Eye disorders
Central serous chorioretinopathy
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
11/137 • Number of events 20 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
9.5%
6/63 • Number of events 6 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal fissure
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal fistula
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
2/137 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
29.9%
41/137 • Number of events 132 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
28.6%
18/63 • Number of events 41 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
2/137 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
3/137 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
1.5%
2/137 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.2%
14/137 • Number of events 21 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
15.9%
10/63 • Number of events 10 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
3.6%
5/137 • Number of events 5 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
6.3%
4/63 • Number of events 5 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
12.4%
17/137 • Number of events 27 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
20.6%
13/63 • Number of events 23 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
5.1%
7/137 • Number of events 11 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
4.8%
3/63 • Number of events 4 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
5.8%
8/137 • Number of events 13 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
20.6%
13/63 • Number of events 21 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
6.3%
4/63 • Number of events 4 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
1.5%
2/137 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
2.2%
3/137 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
5.1%
7/137 • Number of events 8 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
9.5%
6/63 • Number of events 6 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
General disorders
Swelling face
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchiolitis
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Covid-19
|
2.2%
3/137 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
6.3%
4/63 • Number of events 4 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
2/137 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
3/137 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine increased
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
7.3%
10/137 • Number of events 15 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood potassium decreased
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Cystatin c increased
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 4 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
4.4%
6/137 • Number of events 10 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
14.3%
9/63 • Number of events 13 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
Vitamin b12 decreased
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
4.4%
6/137 • Number of events 7 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
11.1%
7/63 • Number of events 8 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.9%
4/137 • Number of events 4 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
7.9%
5/63 • Number of events 6 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
2/137 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
4.8%
3/63 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.9%
4/137 • Number of events 5 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
4.8%
3/63 • Number of events 11 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
6/137 • Number of events 11 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.73%
1/137 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
7.9%
5/63 • Number of events 5 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ageusia
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Burning sensation
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
1.5%
2/137 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
1.5%
2/137 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
6.3%
4/63 • Number of events 6 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
9/137 • Number of events 10 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
12.7%
8/63 • Number of events 8 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.4%
6/137 • Number of events 6 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.5%
2/137 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
4.8%
3/63 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
1.5%
2/137 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
4.8%
3/63 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
2/137 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
3/137 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
1.5%
2/137 • Number of events 2 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
0.00%
0/63 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
4.8%
3/63 • Number of events 3 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.73%
1/137 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/137 • Baseline until end of follow-up (Up To 7 Months)
All participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Baseline until end of follow-up (Up To 7 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