Trial Outcomes & Findings for A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (NCT NCT04211337)
NCT ID: NCT04211337
Last Updated: 2025-04-20
Results Overview
PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria, or death from any cause in the absence of BICR-documented progressive disease. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
291 participants
Primary outcome timeframe
Baseline to Progressive Disease or Death from Any Cause, Whichever Occurs First, Up to 39 Months
Results posted on
2025-04-20
Participant Flow
If a participant has a recorded death on study, or is alive and being followed but off treatment, then the participant can be considered to be study completer. Participants randomized to the Cabozantinib or Vandetanib arm will be allowed to crossover to receive the investigational product at the time of Blinded Independent Committee Review (BICR) confirmed radiographic progression.
Participant milestones
| Measure |
Selpercatinib - Treatment A (TRT A)
160 milligrams (mg) Selpercatinib administered orally (PO) twice daily (BID).
Adolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).
|
Cabozantinib or Vandetanib - Treatment B (TRT B)
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.
Cabozantinib Adolescent Dose: 40 mg/m2.
Vandetanib Adolescent Dose:
* 0.7 - \<0.9 - 100 mg every other day (QOD)
* 0.9 - \<1.2 - 100 mg QD
* 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg
* ≥1.6 - 200 QD
|
|---|---|---|
|
Overall Study
STARTED
|
193
|
98
|
|
Overall Study
Received at Least One Dose of Study Drug
|
193
|
97
|
|
Overall Study
COMPLETED
|
18
|
56
|
|
Overall Study
NOT COMPLETED
|
175
|
42
|
Reasons for withdrawal
| Measure |
Selpercatinib - Treatment A (TRT A)
160 milligrams (mg) Selpercatinib administered orally (PO) twice daily (BID).
Adolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).
|
Cabozantinib or Vandetanib - Treatment B (TRT B)
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.
Cabozantinib Adolescent Dose: 40 mg/m2.
Vandetanib Adolescent Dose:
* 0.7 - \<0.9 - 100 mg every other day (QOD)
* 0.9 - \<1.2 - 100 mg QD
* 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg
* ≥1.6 - 200 QD
|
|---|---|---|
|
Overall Study
On Treatment
|
175
|
40
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Selpercatinib (TRT A)
n=193 Participants
160 milligrams Selpercatinib administered orally (PO) twice daily (BID).
Adolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).
|
Cabozantinib or Vandetanib (TRT B)
n=98 Participants
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.
Cabozantinib Adolescent Dose: 40 mg/m2.
Vandetanib Adolescent Dose:
* 0.7 - \<0.9 - 100 mg every other day (QOD)
* 0.9 - \<1.2 - 100 mg QD
* 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg
* ≥1.6 - 200 QD
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
143 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
215 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
183 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
181 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
275 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
43 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
116 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
168 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
Czechia
|
6 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
9 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Region of Enrollment
India
|
9 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
Russia
|
15 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
9 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Region of Enrollment
Greece
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Region of Enrollment
South Korea
|
10 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
China
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Region of Enrollment
Taiwan
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
20 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
15 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
14 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Region of Enrollment
Israel
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
9 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
France
|
24 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Progressive Disease or Death from Any Cause, Whichever Occurs First, Up to 39 MonthsPopulation: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Censored participants: Selpercatinib - 167; Cabozantinib or Vandetanib - 66
PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria, or death from any cause in the absence of BICR-documented progressive disease. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Outcome measures
| Measure |
Selpercatinib (TRT A)
n=193 Participants
160 milligrams Selpercatinib administered orally (PO) twice daily (BID).
Adolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).
|
Cabozantinib or Vandetanib (TRT B)
n=98 Participants
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.
Cabozantinib Adolescent Dose: 40 mg/m2.
Vandetanib Adolescent Dose:
* 0.7 - \<0.9 - 100 mg every other day (QOD)
* 0.9 - \<1.2 - 100 mg QD
* 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg
* ≥1.6 - 200 QD
|
|---|---|---|
|
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
|
NA Months
Data unavailable due to high censoring.
|
16.76 Months
Interval 12.22 to 25.1
|
SECONDARY outcome
Timeframe: Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause Up to 39 MonthsPopulation: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Censored participants: Selpercatinib - 166; Cabozantinib or Vandetanib - 61
TFFS by BICR is defined as the time from randomization to the first occurrence of: * documented radiographic disease progression per RECIST 1.1 as assessed by BICR; or * unacceptable toxicity leading to treatment discontinuation as assessed by the investigator. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. To qualify as an event, the toxicity must be from an intolerable AE (defined as any study drug-related AE that meets protocol guidance for treatment discontinuation, with the exception of alopecia); or death (due to any cause).
Outcome measures
| Measure |
Selpercatinib (TRT A)
n=193 Participants
160 milligrams Selpercatinib administered orally (PO) twice daily (BID).
Adolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).
|
Cabozantinib or Vandetanib (TRT B)
n=98 Participants
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.
Cabozantinib Adolescent Dose: 40 mg/m2.
Vandetanib Adolescent Dose:
* 0.7 - \<0.9 - 100 mg every other day (QOD)
* 0.9 - \<1.2 - 100 mg QD
* 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg
* ≥1.6 - 200 QD
|
|---|---|---|
|
Treatment Failure-Free Survival (TFFS) by Blinded Independent Committee Review (BICR)
|
NA Months
Data not available due to high censoring.
|
13.93 Months
Interval 11.27 to 25.1
|
SECONDARY outcome
Timeframe: Baseline through Disease Progression or Death Up to 39 MonthsPopulation: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.
ORR is defined as the number of participants who achieved the best overall response (BOR) of CR or PR divided by the total number of participants randomized to each treatment arm. ORR per RECIST 1.1 as assessed by BICR.
Outcome measures
| Measure |
Selpercatinib (TRT A)
n=193 Participants
160 milligrams Selpercatinib administered orally (PO) twice daily (BID).
Adolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).
|
Cabozantinib or Vandetanib (TRT B)
n=98 Participants
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.
Cabozantinib Adolescent Dose: 40 mg/m2.
Vandetanib Adolescent Dose:
* 0.7 - \<0.9 - 100 mg every other day (QOD)
* 0.9 - \<1.2 - 100 mg QD
* 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg
* ≥1.6 - 200 QD
|
|---|---|---|
|
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR
|
69.4 Percentage of Participants
Interval 62.4 to 75.8
|
38.8 Percentage of Participants
Interval 29.1 to 49.2
|
SECONDARY outcome
Timeframe: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 39 MonthsPopulation: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Censored participants: Selpercatinib - 119, Cabozantinib or Vandetanib - 25
DoR by BICR is defined as the time from the date that measurement criteria for complete response (CR) or partial response (PR) (whichever is first recorded) are first met by the BICR or investigator assessment, as applicable, until the first date that disease is recurrent or documented disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Outcome measures
| Measure |
Selpercatinib (TRT A)
n=134 Participants
160 milligrams Selpercatinib administered orally (PO) twice daily (BID).
Adolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).
|
Cabozantinib or Vandetanib (TRT B)
n=38 Participants
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.
Cabozantinib Adolescent Dose: 40 mg/m2.
Vandetanib Adolescent Dose:
* 0.7 - \<0.9 - 100 mg every other day (QOD)
* 0.9 - \<1.2 - 100 mg QD
* 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg
* ≥1.6 - 200 QD
|
|---|---|---|
|
Duration of Response (DoR) by BICR
|
NA Months
Data not available due to high censoring.
|
16.56 Months
Interval 10.41 to
Upper level Confidence Interval not available due to high censoring.
|
SECONDARY outcome
Timeframe: BaselineOverall survival (OS) is defined as the time from randomization until death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineProgression-free survival 2 (PFS2) is defined as the time from randomization to disease progression (radiographic or symptomatic progression as determined by the investigator) on the next line of treatment or death from any cause in the absence of observed disease progression. If the participant is alive at the cutoff for analysis, and disease progression has not been observed, PFS2 data will be censored on the latest date of last progression-free assessment or start of the next line of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause Up to 39 MonthsPopulation: All participants who received the first dose of study treatment prior to the interim efficacy analysis and at least 6 months prior to the data cutoff date. Analysis of tolerability will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated").
Comparative tolerability defined as a comparison of the proportion of time on treatment with high side effect bother as assessed by the FACT-GP5. The FACT-GP5 is a single question used to assess the overall bother of the treatment side effects. It is scored using a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much), where lower scores reflect less bother from treatment side effects. Time with high side effect bother (i.e.) score of 3 or 4 is reported here and was derived as follows: cumulative amount of time, in weeks, during which a participant reports high side effect bother divided by the total duration of therapy (weeks), derived as (date of last study treatment dose - date of first study treatment dose + 1) divided by 7.
Outcome measures
| Measure |
Selpercatinib (TRT A)
n=145 Participants
160 milligrams Selpercatinib administered orally (PO) twice daily (BID).
Adolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).
|
Cabozantinib or Vandetanib (TRT B)
n=77 Participants
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.
Cabozantinib Adolescent Dose: 40 mg/m2.
Vandetanib Adolescent Dose:
* 0.7 - \<0.9 - 100 mg every other day (QOD)
* 0.9 - \<1.2 - 100 mg QD
* 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg
* ≥1.6 - 200 QD
|
|---|---|---|
|
Comparative Tolerability: Number of Weeks With High Side Effect Bother Based Score of 3 or 4 on the Functional Assessment of Cancer Therapy Item GP5 (FACT-GP5)
|
0.08 Weeks
Standard Deviation 0.169
|
0.24 Weeks
Standard Deviation 0.304
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
Outcome data not reported
Adverse Events
Selpercatinib - Treatment A (TRT A)
Serious events: 43 serious events
Other events: 184 other events
Deaths: 8 deaths
Cabozantinib or Vandetanib - Treatment B (TRT B)
Serious events: 27 serious events
Other events: 96 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Selpercatinib - Treatment A (TRT A)
n=193 participants at risk
160 milligrams Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).
|
Cabozantinib or Vandetanib - Treatment B (TRT B)
n=97 participants at risk
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.
Cabozantinib Adolescent Dose: 40 mg/m2.
Vandetanib Adolescent Dose:
0.7 - \<0.9 - 100 mg every other day (QOD) 0.9 - \<1.2 - 100 mg QD 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg
≥1.6 - 200 QD
|
|---|---|---|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.52%
1/193 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Hypothyroidism
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Retinopathy
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Anal cyst
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Enteritis
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
2/97 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 3 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Complication associated with device
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
General physical health deterioration
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pain
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
1.6%
3/193 • Number of events 5 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Sudden death
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.52%
1/193 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Jaundice
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Liver injury
|
0.52%
1/193 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Dengue fever
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis escherichia coli
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Peritonitis bacterial
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
1.6%
3/193 • Number of events 3 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
2/193 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urosepsis
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Fibrin d dimer increased
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Lipase increased
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Liver function test increased
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.52%
1/193 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.87%
1/115 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/67 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Motor dysfunction
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Seizure
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Product Issues
Device occlusion
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
1.3%
1/78 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/30 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Pelvic organ prolapse
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.52%
1/193 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Colporrhaphy
|
1.3%
1/78 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/30 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Proctectomy
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Aortic stenosis
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/97 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
1.0%
2/193 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.1%
4/97 • Number of events 4 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Orthostatic hypotension
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Selpercatinib - Treatment A (TRT A)
n=193 participants at risk
160 milligrams Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).
|
Cabozantinib or Vandetanib - Treatment B (TRT B)
n=97 participants at risk
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice.
Cabozantinib Adolescent Dose: 40 mg/m2.
Vandetanib Adolescent Dose:
0.7 - \<0.9 - 100 mg every other day (QOD) 0.9 - \<1.2 - 100 mg QD 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg
≥1.6 - 200 QD
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
11/193 • Number of events 12 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
10/97 • Number of events 16 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.2%
10/193 • Number of events 13 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
6/97 • Number of events 7 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.2%
10/193 • Number of events 16 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.1%
4/97 • Number of events 4 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.6%
3/193 • Number of events 6 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.2%
8/97 • Number of events 17 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.1%
4/193 • Number of events 5 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.3%
9/97 • Number of events 10 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Hypothyroidism
|
6.2%
12/193 • Number of events 18 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.1%
4/97 • Number of events 4 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.2%
10/193 • Number of events 16 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
2/97 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.8%
19/193 • Number of events 28 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.4%
14/97 • Number of events 30 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
16/193 • Number of events 19 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.2%
7/97 • Number of events 12 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ascites
|
5.7%
11/193 • Number of events 11 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
16.1%
31/193 • Number of events 58 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.4%
12/97 • Number of events 14 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.4%
51/193 • Number of events 116 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
60.8%
59/97 • Number of events 195 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
31.6%
61/193 • Number of events 72 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
10/97 • Number of events 12 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.8%
19/193 • Number of events 21 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.2%
8/97 • Number of events 14 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
6/193 • Number of events 7 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
6/97 • Number of events 7 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.1%
8/193 • Number of events 11 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.2%
8/97 • Number of events 11 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
10.4%
20/193 • Number of events 36 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
32.0%
31/97 • Number of events 54 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oral pain
|
1.6%
3/193 • Number of events 3 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
5/97 • Number of events 11 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
3.6%
7/193 • Number of events 8 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.5%
15/97 • Number of events 32 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
1.6%
3/193 • Number of events 4 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
5/97 • Number of events 5 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
15/193 • Number of events 20 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.6%
20/97 • Number of events 25 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Asthenia
|
10.9%
21/193 • Number of events 31 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
24.7%
24/97 • Number of events 40 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Face oedema
|
7.8%
15/193 • Number of events 19 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
2/97 • Number of events 3 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
18.7%
36/193 • Number of events 61 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.6%
20/97 • Number of events 43 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Mucosal inflammation
|
7.3%
14/193 • Number of events 17 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.8%
25/97 • Number of events 79 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
16.6%
32/193 • Number of events 42 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
2/97 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pain
|
3.6%
7/193 • Number of events 8 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
6/97 • Number of events 9 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
11.4%
22/193 • Number of events 29 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
2/97 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
2.6%
5/193 • Number of events 10 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
5/97 • Number of events 7 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
9.8%
19/193 • Number of events 19 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
17.5%
17/97 • Number of events 17 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
11/193 • Number of events 13 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.2%
8/97 • Number of events 11 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
26.4%
51/193 • Number of events 139 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
34.0%
33/97 • Number of events 57 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
23.8%
46/193 • Number of events 105 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
38.1%
37/97 • Number of events 60 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.8%
19/193 • Number of events 37 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.4%
13/97 • Number of events 16 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
10.9%
21/193 • Number of events 47 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.2%
8/97 • Number of events 12 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
9.3%
18/193 • Number of events 41 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
2/97 • Number of events 4 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.7%
9/193 • Number of events 11 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.4%
14/97 • Number of events 17 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
6.7%
13/193 • Number of events 16 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.4%
13/97 • Number of events 14 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Electrocardiogram qt prolonged
|
13.5%
26/193 • Number of events 67 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.4%
13/97 • Number of events 22 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
5.2%
10/193 • Number of events 24 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.3%
9/97 • Number of events 22 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Platelet count decreased
|
6.2%
12/193 • Number of events 16 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.2%
7/97 • Number of events 17 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
5.2%
10/193 • Number of events 10 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
27.8%
27/97 • Number of events 49 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight increased
|
11.4%
22/193 • Number of events 44 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
2/97 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
8.8%
17/193 • Number of events 33 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.3%
9/97 • Number of events 21 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.9%
23/193 • Number of events 29 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
27.8%
27/97 • Number of events 45 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.2%
10/193 • Number of events 22 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/97 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.7%
13/193 • Number of events 21 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
2/97 • Number of events 2 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.4%
20/193 • Number of events 43 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.8%
25/97 • Number of events 56 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.2%
10/193 • Number of events 16 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.5%
15/97 • Number of events 33 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.2%
10/193 • Number of events 15 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.2%
7/97 • Number of events 13 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.2%
10/193 • Number of events 24 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.1%
4/97 • Number of events 5 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
15/193 • Number of events 16 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.4%
12/97 • Number of events 16 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
12/193 • Number of events 18 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.3%
11/97 • Number of events 11 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
7/193 • Number of events 8 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
5/97 • Number of events 8 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.2%
8/97 • Number of events 10 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
12/193 • Number of events 19 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
5/97 • Number of events 6 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
5.7%
11/193 • Number of events 13 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
10/97 • Number of events 15 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dysgeusia
|
5.2%
10/193 • Number of events 10 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.5%
16/97 • Number of events 19 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
22.8%
44/193 • Number of events 70 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.6%
20/97 • Number of events 22 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
2.1%
4/193 • Number of events 6 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.2%
7/97 • Number of events 7 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
3.1%
6/193 • Number of events 10 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
5/97 • Number of events 5 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.2%
8/97 • Number of events 13 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Proteinuria
|
1.6%
3/193 • Number of events 3 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
23.7%
23/97 • Number of events 44 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.4%
12/115 • Number of events 15 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/67 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
18/193 • Number of events 25 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.2%
7/97 • Number of events 8 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.6%
3/193 • Number of events 3 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
5/97 • Number of events 7 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
9/193 • Number of events 11 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
5/97 • Number of events 8 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.1%
8/193 • Number of events 17 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
5/97 • Number of events 7 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.1%
6/193 • Number of events 8 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
6/97 • Number of events 8 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.1%
4/193 • Number of events 5 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
6/97 • Number of events 6 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.2%
10/193 • Number of events 10 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.2%
7/97 • Number of events 7 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.52%
1/193 • Number of events 1 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.2%
7/97 • Number of events 8 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
13/193 • Number of events 16 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.3%
11/97 • Number of events 11 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/193 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.2%
7/97 • Number of events 10 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
3.6%
7/193 • Number of events 7 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
42.3%
41/97 • Number of events 93 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
7/193 • Number of events 9 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
5/97 • Number of events 6 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.5%
28/193 • Number of events 36 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.6%
20/97 • Number of events 39 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
42.5%
82/193 • Number of events 158 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
40.2%
39/97 • Number of events 76 • Baseline up to 39 months
All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60