Trial Outcomes & Findings for Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (NCT NCT04647526)
NCT ID: NCT04647526
Last Updated: 2026-01-13
Results Overview
* rPFS, as assessed by blinded independent central review (BICR), is the time from the randomization date to progression on soft tissue per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or confirmed progression on bone lesions by Prostate Cancer Working Group 3 (PCWG3) criteria, or death from any cause. * The date of disease progression is the date of the scan for the first objectively documented progressive disease (PD) per RECIST v1.1 or PCWG3. PD is defined as a ≥20% increase in the sum of the diameters of target lesions (≥5 mm absolute), with reference being the smallest sum in the study, or unequivocal progression of non-target lesions, or appearance of new lesions. * Participants who do not progress, including those who started new anticancer therapy, withdrew from the study, or were lost to follow-up without disease progression, were censored at the last valid assessment for RECIST v1.1 or PCWG3.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
455 participants
Primary outcome timeframe
From the randomization date to the first documented progressive disease or death from any cause (up to 23 months)
Results posted on
2026-01-13
Participant Flow
The study includes: * Lead-in dosimetry phase to evaluate the dosimetry of \[Lu-177\]-PNT2002 across standard organs such as the kidneys, salivary and lacrimal glands. * Randomization phase to compare the efficacy of \[Lu-177\]-PNT2002 versus enzalutamide or abiraterone (control arm). Additionally, there is a pharmacokinetic (PK) extension phase, in which participants were enrolled at selected sites in the United States and Canada for PK assessments of \[Lu-177\]-PNT2002.
(continued.,) Participants were unique to each phase of the study, those participated in one phase did not transition to any other phase. All participants will be followed in the long-term follow-up phase for at least five years from the date of their first therapeutic dose, or until death or loss to follow-up, whichever occurs first.
Participant milestones
| Measure |
Lead-in Dosimetry Phase: [Lu-177]-PNT2002
Participants received 6.8 gigabecquerels (GBq) (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: [Lu-177]-PNT2002 (Arm A)
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: Abiraterone or Enzalutamide (Arm B)
Participants received either of below treatments until radiographic progression.
* Enzalutamide 160 milligram (mg) orally once daily (or)
* Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily.
Participants who experienced radiographic progression per Blinded Independent Central Review (BICR) (or after final overall survival (OS), per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled adverse events (AEs) were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles.
|
PK Extension Phase: [Lu-177]-PNT2002
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
276
|
136
|
16
|
|
Overall Study
Intent-to-Treat Analysis (ITT) Set
|
0
|
276
|
136
|
0
|
|
Overall Study
Participants on Arm B Treatment Who Crossed Over to [Lu-177]-PNT2002
|
0
|
0
|
77
|
0
|
|
Overall Study
Safety Analysis Set
|
27
|
269
|
130
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
27
|
276
|
136
|
16
|
Reasons for withdrawal
| Measure |
Lead-in Dosimetry Phase: [Lu-177]-PNT2002
Participants received 6.8 gigabecquerels (GBq) (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: [Lu-177]-PNT2002 (Arm A)
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: Abiraterone or Enzalutamide (Arm B)
Participants received either of below treatments until radiographic progression.
* Enzalutamide 160 milligram (mg) orally once daily (or)
* Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily.
Participants who experienced radiographic progression per Blinded Independent Central Review (BICR) (or after final overall survival (OS), per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled adverse events (AEs) were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles.
|
PK Extension Phase: [Lu-177]-PNT2002
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
|---|---|---|---|---|
|
Overall Study
Death
|
13
|
76
|
32
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
15
|
8
|
1
|
|
Overall Study
Incorrect enrollment
|
0
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
|
Overall Study
Ongoing
|
9
|
183
|
93
|
15
|
Baseline Characteristics
Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment
Baseline characteristics by cohort
| Measure |
Lead-in Dosimetry Phase: [Lu-177]-PNT2002
n=27 Participants
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: [Lu-177]-PNT2002 (Arm A)
n=276 Participants
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: Abiraterone or Enzalutamide (Arm B)
n=136 Participants
Participants received either of below treatments until radiographic progression.
* Enzalutamide 160 mg orally once daily (or)
* Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily.
Participants who experienced radiographic progression per BICR (or after final OS, per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled AEs were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles.
|
PK Extension Phase: [Lu-177]-PNT2002
n=16 Participants
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=210 Participants
|
52 Participants
n=19 Participants
|
27 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
86 Participants
n=615 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=210 Participants
|
224 Participants
n=19 Participants
|
109 Participants
n=123 Participants
|
16 Participants
n=123 Participants
|
369 Participants
n=615 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=210 Participants
|
276 Participants
n=19 Participants
|
136 Participants
n=123 Participants
|
16 Participants
n=123 Participants
|
455 Participants
n=615 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
5 Participants
n=123 Participants
|
1 Participants
n=123 Participants
|
9 Participants
n=615 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=210 Participants
|
262 Participants
n=19 Participants
|
129 Participants
n=123 Participants
|
15 Participants
n=123 Participants
|
432 Participants
n=615 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
12 Participants
n=19 Participants
|
2 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
14 Participants
n=615 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=210 Participants
|
11 Participants
n=19 Participants
|
2 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
13 Participants
n=615 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=210 Participants
|
32 Participants
n=19 Participants
|
8 Participants
n=123 Participants
|
1 Participants
n=123 Participants
|
45 Participants
n=615 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=210 Participants
|
215 Participants
n=19 Participants
|
112 Participants
n=123 Participants
|
15 Participants
n=123 Participants
|
365 Participants
n=615 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
4 Participants
n=615 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=210 Participants
|
16 Participants
n=19 Participants
|
12 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
28 Participants
n=615 Participants
|
|
Region of Enrollment
Canada
|
12 Participants
n=210 Participants
|
78 Participants
n=19 Participants
|
42 Participants
n=123 Participants
|
1 Participants
n=123 Participants
|
133 Participants
n=615 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=210 Participants
|
11 Participants
n=19 Participants
|
6 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
17 Participants
n=615 Participants
|
|
Region of Enrollment
Sweden
|
0 Participants
n=210 Participants
|
3 Participants
n=19 Participants
|
5 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
8 Participants
n=615 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=210 Participants
|
149 Participants
n=19 Participants
|
65 Participants
n=123 Participants
|
15 Participants
n=123 Participants
|
244 Participants
n=615 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=210 Participants
|
10 Participants
n=19 Participants
|
3 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
13 Participants
n=615 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=210 Participants
|
25 Participants
n=19 Participants
|
15 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
40 Participants
n=615 Participants
|
PRIMARY outcome
Timeframe: From the randomization date to the first documented progressive disease or death from any cause (up to 23 months)Population: All participants from the ITT analysis set. Number of participants censored in \[Lu-177\]-PNT2002 (Arm A)=114, Abiraterone or Enzalutamide (Arm B)=40. The "Overall Number of Participants Analyzed" reported is inclusive of the censored participants.
* rPFS, as assessed by blinded independent central review (BICR), is the time from the randomization date to progression on soft tissue per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or confirmed progression on bone lesions by Prostate Cancer Working Group 3 (PCWG3) criteria, or death from any cause. * The date of disease progression is the date of the scan for the first objectively documented progressive disease (PD) per RECIST v1.1 or PCWG3. PD is defined as a ≥20% increase in the sum of the diameters of target lesions (≥5 mm absolute), with reference being the smallest sum in the study, or unequivocal progression of non-target lesions, or appearance of new lesions. * Participants who do not progress, including those who started new anticancer therapy, withdrew from the study, or were lost to follow-up without disease progression, were censored at the last valid assessment for RECIST v1.1 or PCWG3.
Outcome measures
| Measure |
Randomization Phase: [Lu-177]-PNT2002 (Arm A)
n=276 Participants
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: Abiraterone or Enzalutamide (Arm B)
n=136 Participants
Participants received either of below treatments until radiographic progression.
* Enzalutamide 160 mg orally once daily (or)
* Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily.
Participants who experienced radiographic progression per BICR (or after final OS, per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled AEs were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles.
|
|---|---|---|
|
Randomization Phase: Radiographic Progression-Free Survival (rPFS)
|
9.5 months
Interval 7.4 to 10.0
|
6.0 months
Interval 4.7 to 7.9
|
SECONDARY outcome
Timeframe: Randomization until measured progressive disease (up to 23 months)Population: All participants from the ITT analysis set who had measurable disease at baseline.
* ORR, as assessed by BICR, is the best confirmed overall tumor response of complete response (CR) or partial response (PR) as per RECIST v1.1 ( in the absence of confirmed progression on bone scan assessed by PCWG3). * CR is a disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). * PR is at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), without progression of non-target lesions or appearance of new lesions.
Outcome measures
| Measure |
Randomization Phase: [Lu-177]-PNT2002 (Arm A)
n=97 Participants
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: Abiraterone or Enzalutamide (Arm B)
n=50 Participants
Participants received either of below treatments until radiographic progression.
* Enzalutamide 160 mg orally once daily (or)
* Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily.
Participants who experienced radiographic progression per BICR (or after final OS, per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled AEs were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles.
|
|---|---|---|
|
Randomization Phase: Percentage of Participants With Objective Response Rate (ORR)
|
32.0 percentage of participants
Interval 22.9 to 42.2
|
8.0 percentage of participants
Interval 2.2 to 19.2
|
SECONDARY outcome
Timeframe: From the date of first CR or PR to disease progression or death (up to 16.3 months)Population: All participants from the ITT analysis set who had achieved confirmed CR or PR responses (ORR). Number of participants censored in \[Lu-177\]-PNT2002 (Arm A)=18, Abiraterone or Enzalutamide (Arm B)=1. The "Overall Number of Participants Analyzed" reported is inclusive of the censored participants.
Duration of Response, as assessed by BICR, is the time from the date of first documented confirmed CR or PR as per RECIST v1.1 (in the absence of confirmed progression on bone scan assessed by PCWG3) to the date of first documented radiographic progression or death in the absence of progression. Participants who have attained CR or PR as the best overall response, did not have progressive disease, and did not die will be censored.
Outcome measures
| Measure |
Randomization Phase: [Lu-177]-PNT2002 (Arm A)
n=31 Participants
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: Abiraterone or Enzalutamide (Arm B)
n=4 Participants
Participants received either of below treatments until radiographic progression.
* Enzalutamide 160 mg orally once daily (or)
* Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily.
Participants who experienced radiographic progression per BICR (or after final OS, per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled AEs were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles.
|
|---|---|---|
|
Randomization Phase: Duration of Response
|
9.4 months
Interval 7.6 to 15.0
|
8.3 months
Interval 4.0 to
There were not enough events to estimate the upper limit of the 95% confidence interval.
|
SECONDARY outcome
Timeframe: From the randomization up to 23 monthsPopulation: All participants from the ITT analysis set.
The PSA response rate, as per the PCWG3 criteria, is the percentage of participants achieving a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second PSA assessment conducted at least 3 weeks later.
Outcome measures
| Measure |
Randomization Phase: [Lu-177]-PNT2002 (Arm A)
n=276 Participants
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: Abiraterone or Enzalutamide (Arm B)
n=136 Participants
Participants received either of below treatments until radiographic progression.
* Enzalutamide 160 mg orally once daily (or)
* Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily.
Participants who experienced radiographic progression per BICR (or after final OS, per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled AEs were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles.
|
|---|---|---|
|
Randomization Phase: Percentage of Participants With Prostate-Specific Antigen (PSA) Response Rate
|
30.1 percentage of participants
Interval 24.7 to 35.9
|
12.5 percentage of participants
Interval 7.5 to 19.3
|
SECONDARY outcome
Timeframe: From the randomization up to 23 monthsPopulation: All participants from the ITT analysis set. Number of participants censored in \[Lu-177\]-PNT2002 (Arm A)=133, Abiraterone or Enzalutamide (Arm B)=54. The "Overall Number of Participants Analyzed" reported is inclusive of the censored participants.
bPFS is the time from the date of randomization to the date of the first PSA increase from baseline ≥25% and ≥2 nanograms per milliliter (ng/mL) above nadir confirmed by a second PSA measurement defining progression ≥3 weeks later, as per PCWG3, or death from any cause in the absence of progression. Participants who do not progress or die including those who withdraw from the study or are lost to follow-up will be censored at the time of last valid PSA measurement.
Outcome measures
| Measure |
Randomization Phase: [Lu-177]-PNT2002 (Arm A)
n=276 Participants
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: Abiraterone or Enzalutamide (Arm B)
n=136 Participants
Participants received either of below treatments until radiographic progression.
* Enzalutamide 160 mg orally once daily (or)
* Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily.
Participants who experienced radiographic progression per BICR (or after final OS, per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled AEs were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles.
|
|---|---|---|
|
Randomization Phase: Biochemical Progression-Free Survival (bPFS)
|
7.0 months
Interval 4.8 to 9.9
|
3.9 months
Interval 3.5 to 4.3
|
SECONDARY outcome
Timeframe: 5 yearsTime from the date of randomization until death due to any cause.
Outcome measures
Outcome data not reported
Adverse Events
Dosimetry Phase: [Lu-177]-PNT2002
Serious events: 6 serious events
Other events: 24 other events
Deaths: 13 deaths
Randomization Phase: [Lu-177]-PNT2002 (Arm A)
Serious events: 47 serious events
Other events: 259 other events
Deaths: 76 deaths
Randomization Phase: Abiraterone or Enzalutamide (Arm B) / Abiraterone or Enzalutamide
Serious events: 30 serious events
Other events: 117 other events
Deaths: 32 deaths
Randomization Phase: Abiraterone or Enzalutamide (Arm B) / [Lu-177]-PNT2002
Serious events: 14 serious events
Other events: 59 other events
Deaths: 12 deaths
PK Extension Phase: [Lu-177]-PNT2002
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dosimetry Phase: [Lu-177]-PNT2002
n=27 participants at risk
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 every 8 weeks for 4 cycles.
|
Randomization Phase: [Lu-177]-PNT2002 (Arm A)
n=269 participants at risk
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: Abiraterone or Enzalutamide (Arm B) / Abiraterone or Enzalutamide
n=130 participants at risk
Participants received either of below treatments until radiographic progression.
* Enzalutamide 160 mg orally once daily (or)
* Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily.
|
Randomization Phase: Abiraterone or Enzalutamide (Arm B) / [Lu-177]-PNT2002
n=77 participants at risk
Arm B participants who experienced radiographic progression per BICR (or after final OS, per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled AEs were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles.
|
PK Extension Phase: [Lu-177]-PNT2002
n=15 participants at risk
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
4/269 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Cardiac disorders
Cardiomyopathy alcoholic
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.6%
2/77 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Asthenia
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Death
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Fatigue
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Generalised oedema
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Malaise
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Pain
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.3%
3/130 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Pyrexia
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Covid-19
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Device related infection
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Gangrene
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Influenza
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Osteomyelitis
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.1%
3/269 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Sepsis
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Septic shock
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.1%
3/269 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Investigations
Ecg signs of myocardial ischaemia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Cerebellar infarction
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Seizure
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Syncope
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Product Issues
Device occlusion
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Psychiatric disorders
Confusional state
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.2%
6/269 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Renal and urinary disorders
Haematuria
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Renal and urinary disorders
Urinary retention
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Renal and urinary disorders
Urothelium erosion
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.9%
3/77 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Vascular disorders
Gangrene
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Vascular disorders
Hypotension
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
Other adverse events
| Measure |
Dosimetry Phase: [Lu-177]-PNT2002
n=27 participants at risk
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 every 8 weeks for 4 cycles.
|
Randomization Phase: [Lu-177]-PNT2002 (Arm A)
n=269 participants at risk
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
Randomization Phase: Abiraterone or Enzalutamide (Arm B) / Abiraterone or Enzalutamide
n=130 participants at risk
Participants received either of below treatments until radiographic progression.
* Enzalutamide 160 mg orally once daily (or)
* Abiraterone 1000 mg orally once daily coadministered with prednisone 5 mg orally twice daily or dexamethasone 0.5 mg orally once daily.
|
Randomization Phase: Abiraterone or Enzalutamide (Arm B) / [Lu-177]-PNT2002
n=77 participants at risk
Arm B participants who experienced radiographic progression per BICR (or after final OS, per local investigator-assessment), had not started an intervening treatment, and had no uncontrolled AEs were eligible to consent to cross over to receive 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 intravenous infusion every 8 weeks for 4 cycles.
|
PK Extension Phase: [Lu-177]-PNT2002
n=15 participants at risk
Participants received 6.8 GBq (±10%) of \[Lu-177\]-PNT2002 by intravenous infusion every 8 weeks for 4 cycles.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
6/27 • Number of events 16 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
17.8%
48/269 • Number of events 78 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
10.0%
13/130 • Number of events 25 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
18.2%
14/77 • Number of events 25 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
26.7%
4/15 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.9%
5/269 • Number of events 9 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.3%
3/130 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.3%
2/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.3%
9/269 • Number of events 12 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.6%
2/77 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.4%
2/27 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.9%
5/269 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.6%
2/77 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.4%
2/27 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.0%
8/269 • Number of events 14 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.6%
2/77 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
20.0%
3/15 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.1%
11/269 • Number of events 14 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.6%
6/130 • Number of events 7 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.9%
3/77 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Constipation
|
7.4%
2/27 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
20.1%
54/269 • Number of events 62 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
17.7%
23/130 • Number of events 25 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.9%
3/77 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
14.9%
40/269 • Number of events 46 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
10.0%
13/130 • Number of events 18 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
7.8%
6/77 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
20.0%
3/15 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Dry mouth
|
25.9%
7/27 • Number of events 7 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
37.2%
100/269 • Number of events 116 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
24.7%
19/77 • Number of events 23 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
33.3%
5/15 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
3/27 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.1%
4/130 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.9%
5/269 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.6%
2/77 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Nausea
|
22.2%
6/27 • Number of events 8 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
31.2%
84/269 • Number of events 105 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
19.2%
25/130 • Number of events 28 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
22.1%
17/77 • Number of events 23 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
10.4%
28/269 • Number of events 33 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.6%
6/130 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
7.8%
6/77 • Number of events 9 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Asthenia
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
5.2%
14/269 • Number of events 17 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.6%
6/130 • Number of events 11 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.6%
2/77 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Chest pain
|
7.4%
2/27 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.3%
2/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Fatigue
|
29.6%
8/27 • Number of events 10 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
53.5%
144/269 • Number of events 184 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
40.0%
52/130 • Number of events 62 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
31.2%
24/77 • Number of events 30 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
46.7%
7/15 • Number of events 8 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Feeling abnormal
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.1%
3/269 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Gait disturbance
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Influenza like illness
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
5.6%
15/269 • Number of events 18 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.1%
4/130 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Oedema peripheral
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
11.2%
30/269 • Number of events 33 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.2%
8/130 • Number of events 8 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.5%
5/77 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
20.0%
3/15 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
General disorders
Pain
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.6%
7/269 • Number of events 7 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.6%
6/130 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.9%
3/77 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Covid-19
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
10.0%
27/269 • Number of events 28 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
7.7%
10/130 • Number of events 11 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.6%
2/77 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.3%
2/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.1%
3/269 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Skin infection
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Infections and infestations
Urinary tract infection
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.5%
12/269 • Number of events 21 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
5.4%
7/130 • Number of events 9 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.3%
2/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Injury, poisoning and procedural complications
Fall
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
7.4%
20/269 • Number of events 21 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.9%
9/130 • Number of events 13 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.1%
3/269 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.2%
6/269 • Number of events 9 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
5.6%
15/269 • Number of events 19 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.8%
5/130 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.5%
5/77 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Investigations
Blood creatinine increased
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
18/269 • Number of events 23 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.1%
4/130 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.6%
2/77 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.0%
8/269 • Number of events 20 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
26.7%
4/15 • Number of events 8 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Investigations
Sputum abnormal
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Investigations
Weight decreased
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.3%
17/269 • Number of events 21 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
12.3%
16/130 • Number of events 21 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
9.1%
7/77 • Number of events 10 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.3%
2/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Investigations
Weight increased
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.1%
3/27 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
14.9%
40/269 • Number of events 46 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.1%
17/130 • Number of events 17 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
10.4%
8/77 • Number of events 10 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
20.0%
3/15 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.3%
9/269 • Number of events 9 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.1%
4/130 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
4/269 • Number of events 8 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.9%
3/77 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
20.0%
3/15 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.9%
5/269 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
5.4%
7/130 • Number of events 7 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.6%
2/77 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
4/269 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.4%
2/27 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.6%
7/269 • Number of events 9 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.3%
3/130 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.9%
3/77 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.2%
6/269 • Number of events 9 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.8%
5/130 • Number of events 7 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.8%
4/27 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
27.9%
75/269 • Number of events 95 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
26.9%
35/130 • Number of events 48 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
19.5%
15/77 • Number of events 18 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.8%
4/27 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
20.8%
56/269 • Number of events 66 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
21.5%
28/130 • Number of events 36 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
10.4%
8/77 • Number of events 12 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.3%
2/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.8%
13/269 • Number of events 15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.6%
6/130 • Number of events 8 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.9%
3/77 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.1%
3/27 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
5.9%
16/269 • Number of events 19 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
7.7%
10/130 • Number of events 10 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.9%
3/77 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.1%
4/130 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.2%
6/269 • Number of events 7 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.3%
3/130 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.8%
4/27 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
10.8%
29/269 • Number of events 32 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.1%
17/130 • Number of events 20 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
7.8%
6/77 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Dizziness
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
18/269 • Number of events 21 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
8.5%
11/130 • Number of events 12 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
7.8%
6/77 • Number of events 8 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.3%
2/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Dysgeusia
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.2%
6/269 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.5%
5/77 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.3%
2/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Headache
|
11.1%
3/27 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
7.4%
20/269 • Number of events 25 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
7.7%
10/130 • Number of events 10 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.9%
3/77 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.3%
2/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Hypoaesthesia
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.2%
6/269 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.1%
4/130 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.3%
2/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Spinal cord oedema
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Nervous system disorders
Tremor
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Psychiatric disorders
Anxiety
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
4/269 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.3%
3/130 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Psychiatric disorders
Confusional state
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Psychiatric disorders
Depression
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.2%
6/269 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.8%
5/130 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.9%
3/77 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Psychiatric disorders
Insomnia
|
3.7%
1/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.5%
12/269 • Number of events 12 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
10.0%
13/130 • Number of events 15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
5.2%
4/77 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
2.2%
6/269 • Number of events 8 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Renal and urinary disorders
Haematuria
|
11.1%
3/27 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.5%
12/269 • Number of events 13 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.6%
6/130 • Number of events 12 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
4/269 • Number of events 4 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.5%
2/130 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Renal and urinary disorders
Urothelium erosion
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
7.4%
2/27 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
8.9%
24/269 • Number of events 25 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.6%
6/130 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.5%
5/77 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.3%
2/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
5.9%
16/269 • Number of events 19 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.8%
5/130 • Number of events 6 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.5%
5/77 • Number of events 5 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.3%
2/15 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.74%
2/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.9%
3/77 • Number of events 3 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/269 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/130 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/27 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.37%
1/269 • Number of events 2 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.77%
1/130 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/77 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
6.7%
1/15 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Vascular disorders
Hot flush
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
4.1%
11/269 • Number of events 12 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
13.1%
17/130 • Number of events 18 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
3.0%
8/269 • Number of events 15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
10.0%
13/130 • Number of events 20 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
1.3%
1/77 • Number of events 1 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
0.00%
0/15 • Baseline up to 26 months
All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all participants in the study were included.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60