Trial Outcomes & Findings for Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms (NCT NCT02043678)
NCT ID: NCT02043678
Last Updated: 2025-02-19
Results Overview
SSE-FS was defined as time (months) from randomization to the earliest of onset date of skeletal symptoms treated with external beam radiotherapy (EBRT), onset date of pathological bone fracture, onset date of spinal cord compression, procedure date of tumor-related orthopedic surgery, or death from any cause. Participants who died without prior SSE and ≥ 13 weeks after the last SSE assessment are censored at the last SSE assessment date. Participants alive at the survival cut-off date are censored at the last date known to be alive. Participants with multiple events are only counted for the category in which the first event occurred. If multiple SSE (component events) occur on the same date for 1 participant, the participant is only counted into 1 category in the order of: spinal cord compression \> bone fracture \> orthopedic surgery \> EBRT.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
806 participants
Primary outcome timeframe
From randomization until first onset of on-study symptomatic skeletal event (SSE) or death, up to 47 months
Results posted on
2025-02-19
Participant Flow
Study was conducted at multiple centers in 19 countries between 30 March 2014 (first participant first visit) and 08 February 2024 (last participant last visit).
Overall, 1144 participants were screened. Of them, 338 participants did not complete screening, 806 participants were randomized to treatment and 786 participants received study treatment. 2 participants randomized to the placebo treatment group unintentionally received 1 radium-223 dichloride dose during the treatment period.
Participant milestones
| Measure |
Radium-223 Dichloride + Abi/Pred
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Overall Study
STARTED
|
401
|
405
|
|
Overall Study
Treated
|
390
|
396
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
401
|
405
|
Reasons for withdrawal
| Measure |
Radium-223 Dichloride + Abi/Pred
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Overall Study
Never treated
|
11
|
9
|
|
Overall Study
AE with clinical progressive disease(PD)
|
20
|
19
|
|
Overall Study
AE without clinical PD
|
54
|
36
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Other
|
10
|
14
|
|
Overall Study
Clinical PD
|
114
|
148
|
|
Overall Study
Radiological PD
|
100
|
90
|
|
Overall Study
Protocol-driven decision point
|
59
|
58
|
|
Overall Study
Withdrawal by Subject
|
16
|
20
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Deterioration of general conditions
|
1
|
1
|
|
Overall Study
Logistical difficulties
|
2
|
0
|
|
Overall Study
Non-compliance with study drug
|
3
|
1
|
|
Overall Study
Physician Decision
|
4
|
3
|
|
Overall Study
Subject decision
|
0
|
1
|
|
Overall Study
Switching to other therapy
|
3
|
2
|
|
Overall Study
Ongoing with commercial abiraterone/prednisone outside study
|
1
|
1
|
|
Overall Study
Missing
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
ITT analysis set with evaluable number of participants
Baseline characteristics by cohort
| Measure |
Radium-223 Dichloride + Abi/Pred
n=401 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=405 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
Total
n=806 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.9 Years
STANDARD_DEVIATION 8.5 • n=401 Participants
|
71.4 Years
STANDARD_DEVIATION 8.4 • n=405 Participants
|
71.1 Years
STANDARD_DEVIATION 8.5 • n=806 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=401 Participants
|
0 Participants
n=405 Participants
|
0 Participants
n=806 Participants
|
|
Sex: Female, Male
Male
|
401 Participants
n=401 Participants
|
405 Participants
n=405 Participants
|
806 Participants
n=806 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=401 Participants
|
23 Participants
n=405 Participants
|
40 Participants
n=806 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
361 Participants
n=401 Participants
|
355 Participants
n=405 Participants
|
716 Participants
n=806 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=401 Participants
|
27 Participants
n=405 Participants
|
50 Participants
n=806 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=401 Participants
|
1 Participants
n=405 Participants
|
2 Participants
n=806 Participants
|
|
Race (NIH/OMB)
Asian
|
79 Participants
n=401 Participants
|
78 Participants
n=405 Participants
|
157 Participants
n=806 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=401 Participants
|
0 Participants
n=405 Participants
|
0 Participants
n=806 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=401 Participants
|
16 Participants
n=405 Participants
|
26 Participants
n=806 Participants
|
|
Race (NIH/OMB)
White
|
285 Participants
n=401 Participants
|
284 Participants
n=405 Participants
|
569 Participants
n=806 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=401 Participants
|
0 Participants
n=405 Participants
|
0 Participants
n=806 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=401 Participants
|
26 Participants
n=405 Participants
|
52 Participants
n=806 Participants
|
|
Weight
|
82.19 Kilograms (kg)
STANDARD_DEVIATION 16.75 • n=396 Participants • ITT analysis set with evaluable number of participants
|
82.40 Kilograms (kg)
STANDARD_DEVIATION 16.01 • n=400 Participants • ITT analysis set with evaluable number of participants
|
82.30 Kilograms (kg)
STANDARD_DEVIATION 16.37 • n=796 Participants • ITT analysis set with evaluable number of participants
|
|
Stage of prostate cancer at diagnosis (Tumor Node Metastasis [TNM] Classification)
Missing
|
19 Participants
n=401 Participants
|
24 Participants
n=405 Participants
|
43 Participants
n=806 Participants
|
|
Stage of prostate cancer at diagnosis (Tumor Node Metastasis [TNM] Classification)
Stage I
|
27 Participants
n=401 Participants
|
18 Participants
n=405 Participants
|
45 Participants
n=806 Participants
|
|
Stage of prostate cancer at diagnosis (Tumor Node Metastasis [TNM] Classification)
Stage IIA
|
22 Participants
n=401 Participants
|
20 Participants
n=405 Participants
|
42 Participants
n=806 Participants
|
|
Stage of prostate cancer at diagnosis (Tumor Node Metastasis [TNM] Classification)
Stage IIB
|
34 Participants
n=401 Participants
|
49 Participants
n=405 Participants
|
83 Participants
n=806 Participants
|
|
Stage of prostate cancer at diagnosis (Tumor Node Metastasis [TNM] Classification)
Stage III
|
102 Participants
n=401 Participants
|
88 Participants
n=405 Participants
|
190 Participants
n=806 Participants
|
|
Stage of prostate cancer at diagnosis (Tumor Node Metastasis [TNM] Classification)
Stage IV
|
197 Participants
n=401 Participants
|
206 Participants
n=405 Participants
|
403 Participants
n=806 Participants
|
|
Cancer pain assessment by Brief Pain Inventory-Short Form (BPI-SF)
Missing
|
25 Participants
n=401 Participants
|
33 Participants
n=405 Participants
|
58 Participants
n=806 Participants
|
|
Cancer pain assessment by Brief Pain Inventory-Short Form (BPI-SF)
Asymptomatic (Worst pain score = 0)
|
195 Participants
n=401 Participants
|
198 Participants
n=405 Participants
|
393 Participants
n=806 Participants
|
|
Cancer pain assessment by Brief Pain Inventory-Short Form (BPI-SF)
Mildly Symptomatic (Worst pain score 1 - 3)
|
181 Participants
n=401 Participants
|
174 Participants
n=405 Participants
|
355 Participants
n=806 Participants
|
|
Gleason score at diagnosis
Missing
|
15 Participants
n=401 Participants
|
18 Participants
n=405 Participants
|
33 Participants
n=806 Participants
|
|
Gleason score at diagnosis
Less than (<) 8
|
140 Participants
n=401 Participants
|
154 Participants
n=405 Participants
|
294 Participants
n=806 Participants
|
|
Gleason score at diagnosis
Greater than or equal to (>=) 8
|
246 Participants
n=401 Participants
|
233 Participants
n=405 Participants
|
479 Participants
n=806 Participants
|
|
Prostate-specific antigen
|
92.39 Micrograms per liter (ug/L)
STANDARD_DEVIATION 191.62 • n=396 Participants • ITT set with evaluable number of participants.
|
92.33 Micrograms per liter (ug/L)
STANDARD_DEVIATION 328.00 • n=401 Participants • ITT set with evaluable number of participants.
|
92.36 Micrograms per liter (ug/L)
STANDARD_DEVIATION 268.85 • n=797 Participants • ITT set with evaluable number of participants.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
|
2 Participants
n=401 Participants
|
3 Participants
n=405 Participants
|
5 Participants
n=806 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
262 Participants
n=401 Participants
|
281 Participants
n=405 Participants
|
543 Participants
n=806 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
137 Participants
n=401 Participants
|
121 Participants
n=405 Participants
|
258 Participants
n=806 Participants
|
|
Extent of Disease
Normal or abnormal because of benign bone disease
|
2 Participants
n=401 Participants
|
0 Participants
n=405 Participants
|
2 Participants
n=806 Participants
|
|
Extent of Disease
< 6 metastases
|
134 Participants
n=401 Participants
|
141 Participants
n=405 Participants
|
275 Participants
n=806 Participants
|
|
Extent of Disease
6-20 metastases
|
175 Participants
n=401 Participants
|
181 Participants
n=405 Participants
|
356 Participants
n=806 Participants
|
|
Extent of Disease
>20 lesions but not a superscan
|
71 Participants
n=401 Participants
|
70 Participants
n=405 Participants
|
141 Participants
n=806 Participants
|
|
Extent of Disease
Superscan
|
19 Participants
n=401 Participants
|
13 Participants
n=405 Participants
|
32 Participants
n=806 Participants
|
PRIMARY outcome
Timeframe: From randomization until first onset of on-study symptomatic skeletal event (SSE) or death, up to 47 monthsPopulation: Intent-to-Treat (ITT) analysis set (included all randomized participants)
SSE-FS was defined as time (months) from randomization to the earliest of onset date of skeletal symptoms treated with external beam radiotherapy (EBRT), onset date of pathological bone fracture, onset date of spinal cord compression, procedure date of tumor-related orthopedic surgery, or death from any cause. Participants who died without prior SSE and ≥ 13 weeks after the last SSE assessment are censored at the last SSE assessment date. Participants alive at the survival cut-off date are censored at the last date known to be alive. Participants with multiple events are only counted for the category in which the first event occurred. If multiple SSE (component events) occur on the same date for 1 participant, the participant is only counted into 1 category in the order of: spinal cord compression \> bone fracture \> orthopedic surgery \> EBRT.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=401 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=405 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Symptomatic Skeletal Event Free Survival (SSE-FS)
|
22.3 Months
Interval 20.4 to 24.8
|
26.0 Months
Interval 21.8 to 28.3
|
SECONDARY outcome
Timeframe: From randomization until death from any cause, up to 67 monthsPopulation: ITT analysis set (included all randomized participants)
OS was defined as the time (months) from the date of randomization to the date of death due to any cause. Participants alive at the survival cut-off date were censored at the last date known to be alive.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=401 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=405 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Overall Survival (OS)
|
30.1 Months
Interval 27.5 to 33.2
|
34.8 Months
Interval 31.5 to 37.6
|
SECONDARY outcome
Timeframe: From randomization until the date of confirmed radiological progression or death, up to 47 monthsPopulation: ITT analysis set (included all randomized participants)
rPFS was defined as the time (months) from the date of randomization to the date of confirmed radiological progression or death (if death occurred before progression) based on independent assessment.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=401 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=405 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Radiological Progression Free Survival (rPFS)
|
11.2 Months
Interval 9.1 to 11.8
|
12.4 Months
Interval 10.8 to 14.5
|
SECONDARY outcome
Timeframe: From randomization until the date of pain progression based on pain score, up to 47 monthsPopulation: ITT analysis set (included all randomized participants)
Time to pain progression was defined as the interval from randomization to the first date a participant experienced pain progression assessed by Brief Pain Inventory-Short Form and defined as: an increase of 2 or more points in the average worst pain score (WPS) from baseline observed at 2 consecutive evaluations ≥4 weeks apart or initiation of short- or long-acting opioid use for pain for participants with WPS 0 at baseline; an increase of 2 or more points in the average WPS from baseline observed at 2 consecutive evaluations ≥4 weeks apart and an average WPS of ≥4 OR initiation of short- or long-acting opioid use for pain for participants with WPS 1 to 3 at baseline. Participants without pain progression at end of study are censored at the last date known to have not progressed: last evaluation date for pain scores or last visit when recorded opiate use, whichever is last. Participants with no on-study assessment or no baseline assessment are censored at the date of randomization.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=401 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=405 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Time to Pain Progression
|
14.4 Months
Interval 11.1 to 20.1
|
18.7 Months
Interval 15.4 to 23.1
|
SECONDARY outcome
Timeframe: From randomization until the date of first cytotoxic chemotherapy, up to 47 monthsPopulation: ITT analysis set (included all randomized participants)
Time to cytotoxic chemotherapy is time (months) from randomization to the earliest date of the first cytotoxic chemotherapy. Participants who have not started cytotoxic chemotherapy during the study were censored at the last assessment date.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=401 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=405 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Time to Cytotoxic Chemotherapy
|
29.5 Months
Interval 26.5 to 35.7
|
28.5 Months
Interval 23.7 to
Upper limit cannot be estimated due to censored data.
|
SECONDARY outcome
Timeframe: From randomization until the date of opiate use, up to 47 monthsPopulation: ITT analysis set excluding participants who had opiate use at baseline
Time to opiate use for cancer pain was defined as the interval from the date of randomization to the date of opiate use.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=398 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=392 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Time to Opiate Use for Cancer Pain
|
19.0 Months
Interval 14.4 to 23.2
|
22.6 Months
Interval 18.0 to 25.7
|
SECONDARY outcome
Timeframe: From start of study treatment until the end of the treatment period, up to 110 monthsPopulation: Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug
An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant in the study. A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was life-threatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. A treatment-emergent AEs (TEAEs) or serious TEAEs was defined as any event that started on or after the first dose of the study treatment and during the treatment period and was not a continuation of a pretreatment event or started before the first dose and worsened after the first dose or the treatment period. Drug-related TEAEs or serious TEAEs were those with "reasonable causal relationship" to the study treatment decided by the investigators.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=392 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=394 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
Any TEAE
|
382 Participants
|
387 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Any drug-related TEAE
|
265 Participants
|
273 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Radium-223/Placebo-related TEAE
|
92 Participants
|
91 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Any serious TEAE
|
178 Participants
|
178 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Any drug-related serious TEAE
|
32 Participants
|
30 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Radium-223/Placebo-related serious TEAE
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment until the end of the treatment period, up to 110 monthsPopulation: Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug
An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant in the study. A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was lifethreatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. A treatment-emergent AEs (TEAEs) or serious TEAEs was defined as any event that started on or after the first dose of the study treatment and during the treatment period and was not a continuation of a pretreatment event or started before the first dose and worsened after the first dose or the treatment period. Radium-223/placebo-related TEAEs or serious TEAEs were those with "reasonable causal relationship" to radium-223 or placebo decided by the investigators.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=392 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=394 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Number of Participants With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity
TEAE - Grade 1
|
43 Participants
|
53 Participants
|
|
Number of Participants With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity
TEAE - Grade 2
|
28 Participants
|
23 Participants
|
|
Number of Participants With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity
TEAE - Grade 3
|
20 Participants
|
13 Participants
|
|
Number of Participants With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity
TEAE - Grade 4
|
1 Participants
|
2 Participants
|
|
Number of Participants With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity
Serious TEAE - Grade 2
|
3 Participants
|
0 Participants
|
|
Number of Participants With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity
Serious TEAE - Grade 3
|
9 Participants
|
5 Participants
|
|
Number of Participants With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity
Serious TEAE - Grade 4
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment until the end of the treatment period, up to 110 monthsPopulation: Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug
Treatment-emergent additional primary malignancies were adverse events identified as additional primary malignancies that occurred after start of study treatment until the end of the treatment period.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=392 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=394 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Additional Primary Malignancies
|
32 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment until the end of the treatment period, up to 110 monthsPopulation: Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug
Treatment-emergent fractures were adverse events identified as fractures that occurred after start of study treatment until the end of the treatment period. All bone fractures and bone-associated events (e.g., osteoporosis) were reported as either AEs, or SAEs if the criteria of SAE were met, regardless of the investigator's causality assessment.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=392 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=394 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Number of Participants With Treatment-emergent Bone Fractures
|
110 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-upPopulation: Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug
An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs that started after the treatment period were defined as post-treatment AEs. Drug-related AEs were those with "reasonable causal relationship" to the study treatment decided by the investigators.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=392 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=394 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Number of Participants With Post-treatment Adverse Events
Any events
|
148 Participants
|
138 Participants
|
|
Number of Participants With Post-treatment Adverse Events
Any drug-related events
|
20 Participants
|
10 Participants
|
|
Number of Participants With Post-treatment Adverse Events
Any chemotherapy-related events
|
31 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-upPopulation: Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug
An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs that started after the treatment period were defined as post-treatment AEs. Drug-related AEs were those with "reasonable causal relationship" to the study treatment decided by the investigators.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=392 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=394 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity
Grade 1
|
34 Participants
|
4 Participants
|
|
Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity
Grade 2
|
9 Participants
|
3 Participants
|
|
Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity
Grade 3
|
6 Participants
|
3 Participants
|
|
Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity
Grade 4
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-upPopulation: Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug
Post-treatment additional primary malignancies were adverse events identified as additional primary malignancies that started after the treatment period.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=392 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=394 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Number of Participants With Post-treatment Additional Primary Malignancies
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-upPopulation: Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug
Post-treatment blood and lymphatic system disorders were adverse events identified as blood and lymphatic system disorders that occurred after the end of the treatment period until participant died, was lost to follow-up, withdrew informed consent, actively objected to collection of further data, or was transitioned to the extended safety follow-up study.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=392 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=394 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders
Anaemia
|
5 Participants
|
4 Participants
|
|
Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders
Myelosuppression
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders
Febrile neutropenia
|
5 Participants
|
8 Participants
|
|
Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders
Leukopenia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders
Neutropenia
|
8 Participants
|
3 Participants
|
|
Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders
Pancytopenia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders
Thrombocytopenia
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-upPopulation: Safety analysis set (SAF): included all randomized participants who received at least one dose of any study drug
Post-treatment fractures were adverse events identified as fractures that occured after the end of the treatment period until participant died, was lost to follow-up, withdrew informed consent, actively objected to collection of further data, or was transitioned to the extended safety follow-up study. All bone fractures and bone-associated events (e.g., osteoporosis), were reported as either AEs, or SAEs if the criteria of SAE were met, regardless of the investigator's causality assessment.
Outcome measures
| Measure |
Radium-223 Dichloride + Abi/Pred
n=392 Participants
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=394 Participants
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Number of Participants With Post-treatment Bone Fractures
Pathological fracture
|
14 Participants
|
14 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Ankle fracture
|
0 Participants
|
1 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Craniofacial fracture
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Femur fracture
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Fibula fracture
|
0 Participants
|
1 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Foot fracture
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Jaw fracture
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Patella fracture
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Radius fracture
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Rib fracture
|
0 Participants
|
1 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Spinal compression fracture
|
0 Participants
|
2 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Thoracic vertebral fracture
|
0 Participants
|
1 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Traumatic fracture
|
0 Participants
|
1 Participants
|
|
Number of Participants With Post-treatment Bone Fractures
Osteoporotic fracture
|
6 Participants
|
0 Participants
|
Adverse Events
Radium-223 Dichloride + Abi/Pred
Serious events: 193 serious events
Other events: 368 other events
Deaths: 287 deaths
Placebo + Abi/Pred
Serious events: 191 serious events
Other events: 376 other events
Deaths: 290 deaths
Serious adverse events
| Measure |
Radium-223 Dichloride + Abi/Pred
n=392 participants at risk
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=394 participants at risk
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
4/392 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
9/392 • Number of events 19 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.0%
4/394 • Number of events 5 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.77%
3/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.5%
6/394 • Number of events 6 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.26%
1/392 • Number of events 6 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.77%
3/392 • Number of events 8 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
4/392 • Number of events 5 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.0%
4/394 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
4/392 • Number of events 5 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
2.0%
8/394 • Number of events 9 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Atrial flutter
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.51%
2/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Cardiac arrest
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Cardiac failure
|
0.51%
2/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.76%
3/394 • Number of events 6 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Coronary ostial stenosis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Myocardial infarction
|
0.77%
3/392 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.77%
3/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Cardiac disorders
Cardiac disorder
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Congenital, familial and genetic disorders
Inborn error of metabolism
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Endocrine disorders
Primary adrenal insufficiency
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Eye disorders
Cataract
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Eye disorders
Retinal artery occlusion
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.77%
3/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.0%
4/394 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.77%
3/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Anal prolapse
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Overflow diarrhoea
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Asthenia
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.0%
4/394 • Number of events 6 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Condition aggravated
|
0.51%
2/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Death
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Fatigue
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Gait disturbance
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Influenza like illness
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Malaise
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Oedema peripheral
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Pain
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Pyrexia
|
1.3%
5/392 • Number of events 5 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.0%
4/394 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Sudden death
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
General physical health deterioration
|
2.3%
9/392 • Number of events 13 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
3.3%
13/394 • Number of events 19 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Physical deconditioning
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Non-cardiac chest pain
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Acute sinusitis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Appendicitis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Bacteraemia
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Cellulitis
|
0.77%
3/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Encephalitis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Erysipelas
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.77%
3/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Infection
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Influenza
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.77%
3/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Lyme disease
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Osteomyelitis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Pneumonia
|
3.1%
12/392 • Number of events 15 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
4.1%
16/394 • Number of events 20 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Sepsis
|
0.51%
2/392 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.0%
4/394 • Number of events 7 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Sinusitis
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Skin infection
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.3%
5/394 • Number of events 6 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Urinary tract infection
|
4.6%
18/392 • Number of events 21 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
2.8%
11/394 • Number of events 13 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Wound infection
|
0.26%
1/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Urosepsis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.5%
6/394 • Number of events 12 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Tooth infection
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Acute endocarditis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Neutropenic sepsis
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Groin infection
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Pulmonary sepsis
|
0.51%
2/392 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Arthritis bacterial
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Arthritis infective
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Respiratory tract infection
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Neurocryptococcosis
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.51%
2/392 • Number of events 6 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.0%
4/394 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.77%
3/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.51%
2/392 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.76%
3/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Pseudophakic bullous keratopathy
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Investigations
Alanine aminotransferase increased
|
0.51%
2/392 • Number of events 6 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.51%
2/392 • Number of events 5 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Investigations
Blood bilirubin increased
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Investigations
Platelet count decreased
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Investigations
Weight decreased
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.51%
2/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 11 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.51%
2/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
4/392 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
6/392 • Number of events 7 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
2.8%
11/394 • Number of events 12 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.8%
7/392 • Number of events 8 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.3%
5/394 • Number of events 8 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.77%
3/392 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
2.3%
9/392 • Number of events 14 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
2.6%
10/392 • Number of events 15 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.0%
4/394 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.77%
3/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.76%
3/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Spinal instability
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Jaw fistula
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.26%
1/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic thyroid cancer
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.77%
3/392 • Number of events 8 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.5%
6/394 • Number of events 13 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 6 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.77%
3/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal sinus cancer
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.0%
8/392 • Number of events 9 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
2.0%
8/394 • Number of events 24 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the small bowel
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.51%
2/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.26%
1/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Alexia
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Dizziness
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Monoplegia
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Neuralgia
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Paraparesis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Presyncope
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Radiculopathy
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Sciatica
|
0.51%
2/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Seizure
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Spinal cord compression
|
1.8%
7/392 • Number of events 7 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
2.3%
9/394 • Number of events 9 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Syncope
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Spinal epidural haematoma
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Cognitive disorder
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Vascular dementia
|
0.26%
1/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.77%
3/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Parkinson's disease
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Psychiatric disorders
Confusional state
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Psychiatric disorders
Delirium
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Psychiatric disorders
Adjustment disorder
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Dysuria
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Haematuria
|
1.3%
5/392 • Number of events 6 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.0%
4/394 • Number of events 5 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.0%
4/394 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.51%
2/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
4/392 • Number of events 5 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.76%
3/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.26%
1/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 7 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
1.0%
4/394 • Number of events 5 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.26%
1/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
6/392 • Number of events 7 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.51%
2/392 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Vascular disorders
Aortic dissection
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Vascular disorders
Circulatory collapse
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Vascular disorders
Hypertension
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Vascular disorders
Hypotension
|
0.51%
2/392 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/392 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.51%
2/394 • Number of events 2 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.51%
2/392 • Number of events 5 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.26%
1/392 • Number of events 4 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.00%
0/394 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.26%
1/392 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
Other adverse events
| Measure |
Radium-223 Dichloride + Abi/Pred
n=392 participants at risk
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \[NIST\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met).
|
Placebo + Abi/Pred
n=394 participants at risk
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.3%
64/392 • Number of events 135 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
15.7%
62/394 • Number of events 129 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
23/392 • Number of events 24 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
4.3%
17/394 • Number of events 20 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Constipation
|
18.1%
71/392 • Number of events 84 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
21.1%
83/394 • Number of events 102 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.1%
71/392 • Number of events 111 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
18.0%
71/394 • Number of events 102 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
20/392 • Number of events 23 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
4.1%
16/394 • Number of events 17 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Nausea
|
19.4%
76/392 • Number of events 92 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
17.5%
69/394 • Number of events 77 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
41/392 • Number of events 49 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
10.7%
42/394 • Number of events 48 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Asthenia
|
9.9%
39/392 • Number of events 50 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
11.2%
44/394 • Number of events 61 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Chest pain
|
5.1%
20/392 • Number of events 22 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
4.8%
19/394 • Number of events 25 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Fatigue
|
27.0%
106/392 • Number of events 152 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
24.6%
97/394 • Number of events 140 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Influenza like illness
|
3.8%
15/392 • Number of events 19 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
5.1%
20/394 • Number of events 24 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Oedema peripheral
|
15.6%
61/392 • Number of events 83 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
17.3%
68/394 • Number of events 81 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
General disorders
Pyrexia
|
7.7%
30/392 • Number of events 35 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
8.6%
34/394 • Number of events 50 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Influenza
|
5.6%
22/392 • Number of events 23 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
3.6%
14/394 • Number of events 22 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
31/392 • Number of events 40 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
9.9%
39/394 • Number of events 54 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
29/392 • Number of events 42 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
8.9%
35/394 • Number of events 47 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Infections and infestations
Urinary tract infection
|
10.2%
40/392 • Number of events 55 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
8.6%
34/394 • Number of events 41 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
15.6%
61/392 • Number of events 93 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
13.2%
52/394 • Number of events 78 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
5.6%
22/392 • Number of events 37 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
4.3%
17/394 • Number of events 39 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
28/392 • Number of events 38 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
8.4%
33/394 • Number of events 41 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Investigations
Alanine aminotransferase increased
|
17.6%
69/392 • Number of events 180 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
15.5%
61/394 • Number of events 151 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
15.6%
61/392 • Number of events 127 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
14.0%
55/394 • Number of events 106 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Investigations
Weight decreased
|
5.9%
23/392 • Number of events 37 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
6.3%
25/394 • Number of events 39 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.1%
12/392 • Number of events 18 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
5.8%
23/394 • Number of events 50 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.0%
43/392 • Number of events 81 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
11.4%
45/394 • Number of events 87 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.3%
68/392 • Number of events 86 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
13.7%
54/394 • Number of events 58 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.0%
106/392 • Number of events 170 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
26.4%
104/394 • Number of events 197 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
39.3%
154/392 • Number of events 258 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
35.5%
140/394 • Number of events 214 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
18.4%
72/392 • Number of events 103 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
19.3%
76/394 • Number of events 101 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
28/392 • Number of events 34 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
7.6%
30/394 • Number of events 34 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.6%
26/392 • Number of events 40 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
9.4%
37/394 • Number of events 51 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.1%
16/392 • Number of events 20 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
5.6%
22/394 • Number of events 24 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.4%
25/392 • Number of events 29 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
6.1%
24/394 • Number of events 27 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.6%
18/392 • Number of events 19 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
6.6%
26/394 • Number of events 32 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.9%
27/392 • Number of events 28 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.25%
1/394 • Number of events 1 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
6.6%
26/392 • Number of events 75 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
0.76%
3/394 • Number of events 3 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.5%
53/392 • Number of events 75 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
15.0%
59/394 • Number of events 80 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
12.5%
49/392 • Number of events 73 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
7.1%
28/394 • Number of events 43 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
30/392 • Number of events 43 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
8.1%
32/394 • Number of events 40 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
7.9%
31/392 • Number of events 36 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
6.9%
27/394 • Number of events 34 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Dizziness
|
11.5%
45/392 • Number of events 54 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
9.4%
37/394 • Number of events 44 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Nervous system disorders
Headache
|
7.9%
31/392 • Number of events 46 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
7.9%
31/394 • Number of events 38 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Psychiatric disorders
Insomnia
|
8.7%
34/392 • Number of events 37 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
6.6%
26/394 • Number of events 27 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Renal and urinary disorders
Haematuria
|
8.2%
32/392 • Number of events 45 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
5.3%
21/394 • Number of events 29 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.1%
12/392 • Number of events 16 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
5.3%
21/394 • Number of events 31 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.2%
36/392 • Number of events 42 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
10.7%
42/394 • Number of events 53 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.4%
21/392 • Number of events 30 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
8.1%
32/394 • Number of events 36 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Vascular disorders
Hypertension
|
15.8%
62/392 • Number of events 168 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
21.1%
83/394 • Number of events 221 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
|
Vascular disorders
Hot flush
|
6.1%
24/392 • Number of events 26 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
12.9%
51/394 • Number of events 53 • From start of study treatment until last contact, up to 110 months in treatment period, 48.5 months in active follow-up and 74.9 months in long-term follow-up.
Adverse events (AEs) included any event arising or worsening from the start of the study treatment. All occurrences of additional malignancies, chemotherapy-related events, bone fractures and bone associated events were reported as AE regardless of the investigator's causality assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60