Trial Outcomes & Findings for Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer (NCT NCT02258451)
NCT ID: NCT02258451
Last Updated: 2023-11-24
Results Overview
Time from date of randomization to occurrence of one of the following, whichever happened earlier: 1) an on study SSE, which was defined as the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms, the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral), the occurrence of spinal cord compression, a tumor related orthopedic surgical intervention; or 2) death from any cause. Per Protocol Amendment 10, following primary analysis completion, further assessments were focused on safety, and only limited efficacy data including SSE and survival were collected and not designed to support reconsideration of the primary analysis efficacy conclusions. Accordingly, no formal statistical analyses were performed for primary and secondary efficacy outcomes in the final analysis. All primary and secondary efficacy outcome measures presented in this document came from the primary completion analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
283 participants
Primary outcome timeframe
Up to 55 months
Results posted on
2023-11-24
Participant Flow
The study was conducted with first participant first visit on 04-JUN-2015 and last participant last visit on 28-OCT-2022.
Overall, 389 participants were screened and 283 were assigned to treatment. Of these, 142 in the radium 223 dichloride arm and 141 in the placebo arm.
Participant milestones
| Measure |
Radium-223 + EXE/EVE
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
141
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
142
|
141
|
Reasons for withdrawal
| Measure |
Radium-223 + EXE/EVE
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Overall Study
Discontinuation all treatment due to progressive disease - radiological progression
|
90
|
101
|
|
Overall Study
Discontinuation all treatment due to progressive disease - clinical progression
|
7
|
7
|
|
Overall Study
Discontinuation all treatment due to adverse event not associated with clinical disease progression
|
8
|
1
|
|
Overall Study
Discontinuation all treatment due to adverse event associated with clinical disease progression
|
8
|
6
|
|
Overall Study
Discontinuation all treatment due to death
|
4
|
3
|
|
Overall Study
Discontinuation all treatment due to withdrawal by participant
|
21
|
13
|
|
Overall Study
Discontinuation all treatment due to end point reached
|
1
|
1
|
|
Overall Study
Discontinuation all treatment due to physician decision
|
0
|
2
|
|
Overall Study
Discontinuation all treatment due to study terminated by sponsor
|
0
|
3
|
|
Overall Study
Other reason
|
1
|
1
|
|
Overall Study
Never treated
|
2
|
3
|
Baseline Characteristics
Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Radium-223 + EXE/EVE
n=142 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=141 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Total
n=283 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.95 Years
STANDARD_DEVIATION 10.40 • n=93 Participants
|
59.08 Years
STANDARD_DEVIATION 11.64 • n=4 Participants
|
59.52 Years
STANDARD_DEVIATION 11.02 • n=27 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=93 Participants
|
141 Participants
n=4 Participants
|
283 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=93 Participants
|
125 Participants
n=4 Participants
|
252 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 55 monthsPopulation: Intent to treat analysis set: all randomized participants
Time from date of randomization to occurrence of one of the following, whichever happened earlier: 1) an on study SSE, which was defined as the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms, the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral), the occurrence of spinal cord compression, a tumor related orthopedic surgical intervention; or 2) death from any cause. Per Protocol Amendment 10, following primary analysis completion, further assessments were focused on safety, and only limited efficacy data including SSE and survival were collected and not designed to support reconsideration of the primary analysis efficacy conclusions. Accordingly, no formal statistical analyses were performed for primary and secondary efficacy outcomes in the final analysis. All primary and secondary efficacy outcome measures presented in this document came from the primary completion analysis.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=142 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=141 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Symptomatic Skeletal Event-free Survival (SSE-FS)
|
21.1 Months
Interval 17.1 to 23.6
|
19.9 Months
Interval 16.2 to 24.2
|
SECONDARY outcome
Timeframe: Up to 55 monthsPopulation: Intent to treat analysis set: all randomized participants
The time from the date of randomization to the date of death due to any cause. Per Protocol Amendment 10, following primary analysis completion, further assessments were focused on safety, and only limited efficacy data including SSE and survival were collected and not designed to support reconsideration of the primary analysis efficacy conclusions. Accordingly, no formal statistical analyses were performed for primary and secondary efficacy outcomes in the final analysis. All primary and secondary efficacy outcome measures presented in this document came from the primary completion analysis.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=142 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=141 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Overall Survival
|
25.0 Months
Interval 23.0 to 31.4
|
26.4 Months
Interval 21.7 to 28.9
|
SECONDARY outcome
Timeframe: Up to 55 monthsPopulation: Safety analysis set: all randomized participants who received at least one dose of any study medication (radium 223 dichloride or placebo, exemestane, and everolimus). Participants were assigned to the Radium-223 dichloride arm if they received any dose of Radium-223 dichloride, otherwise to the placebo arm.
Interval from the date of randomization to the date of opiate use
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=139 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=139 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Time to Opiate Use for Cancer Pain
|
21.4 Months
Interval 13.2 to
N/A = Value cannot be estimated due to censored data. Insufficient number of participants with events.
|
18.4 Months
Interval 8.3 to
N/A = Value cannot be estimated due to censored data. Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 55 monthsPopulation: Safety analysis set: all randomized participants who received at least one dose of any study medication (radium 223 dichloride or placebo, exemestane, and everolimus). Participants were assigned to the Radium-223 dichloride arm if they received any dose of Radium-223 dichloride, otherwise to the placebo arm.
Time from randomization to the first date a participant experienced pain progression based on WPS. Pain progression was defined as an increase of 2 or more points in the BPI-SF "Worst pain in 24 hours" score from baseline observed at 2 consecutive evaluations ≥4 weeks apart or an increase in pain management (IPM) with respect to baseline, whichever occurred first. An IPM is defined as the initiation of any opioid in participants not taking opioids at baseline, the initiation of a strong opioid in participants taking a weak opioid at baseline, or the initiation of an additional strong opioid in participants taking a strong opioid at baseline.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=139 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=139 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Time to Pain Progression
|
7.6 Months
Interval 6.2 to 13.2
|
5.7 Months
Interval 4.9 to 8.5
|
SECONDARY outcome
Timeframe: Up to 55 monthsPopulation: ITT analysis set: included all randomized participants
Time from the date of randomization to the date of the first cytotoxic chemotherapy
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=142 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=141 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Time to Cytotoxic Chemotherapy
|
13.7 Months
Interval 9.9 to 15.8
|
11.6 Months
Interval 9.0 to 16.4
|
SECONDARY outcome
Timeframe: Up to 55 monthsPopulation: ITT analysis set: included all randomized participants
Time from the date of randomization to the date of confirmed radiological progression in either soft tissue, viscera or bone, or death (if death occurs before progression). Progression is defined using the modified RECIST 1.1 criteria (the modification refers to bone lesions assessment). Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. All bone lesions are considered non-measurable and new bone lesions identified by bone scan should be confirmed by further imaging (CT/MRI). If a new bone lesion or unequivocal increase in size of bone lesions is only visible on a CT/MRI and not visible on a technetium-99m bone scan, progression should be declared without further confirmation.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=142 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=141 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Radiological Progression-free Survival (rPFS)
|
7.9 Months
Interval 6.2 to 9.7
|
6.7 Months
Interval 5.4 to 8.1
|
SECONDARY outcome
Timeframe: Up to 55 monthsPopulation: Safety analysis set with baseline WPS \>= 2: all randomized participants who received at least one dose of any study medication (radium 223 dichloride or placebo exemestane, or everolimus), and who in addition had baseline BPI-SF WPS \>= 2. Participants were assigned to the Radium-223 dichloride arm if they received any dose of Radium-223 dichloride, otherwise to the placebo arm.
In the percentage of participants with confirmed pain improvement. Confirmed pain improvement is defined a 2-point decrease or more in BPI-SF WPS from baseline over 2 consecutive measurements conducted at least 4 weeks apart, without an increase in pain management (IPM). An IPM is defined as the initiation of any opioid in participants not taking opioids at baseline, the initiation of a strong opioid in participants taking a weak opioid at baseline, or the initiation of an additional strong opioid in participants taking a strong opioid at baseline.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=91 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=96 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Percentage of Participants With Pain Improvement
|
38.5 percentage of participants
Interval 28.4 to 49.2
|
34.4 percentage of participants
Interval 25.0 to 44.8
|
SECONDARY outcome
Timeframe: From first dosing up to 30 days after the last administration of study treatments, up to 72.6 monthsPopulation: Safety analysis set: all randomized participants who received at least one dose of any study medication (radium 223 dichloride or placebo, exemestane, and everolimus). Participants were assigned to the Radium-223 dichloride arm if they received any dose of Radium-223 dichloride, otherwise to the placebo arm.
An AE was any untoward medical occurrence (i.e. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a patient or clinical investigation participant after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they started or worsened after first application of study intervention up to 30 days after end of treatment with study intervention. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly; another medical important serious event as judged by the investigator and an occurrence of any additional malignancies, including acute myelocytic leukemia or hematological conditions.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=139 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=139 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
139 Participants
|
136 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Serious TEAE
|
57 Participants
|
55 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Radium-223/Placebo-related TEAEs
|
73 Participants
|
50 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Exemestane-related TEAEs
|
75 Participants
|
64 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Everolimus-related TEAEs
|
130 Participants
|
125 Participants
|
SECONDARY outcome
Timeframe: From post-treatment till end of study, up to 45.8 monthsPopulation: Safety analysis set: all randomized participants who received at least one dose of any study medication (radium 223 dichloride or placebo, exemestane, and everolimus). Participants were assigned to the Radium-223 dichloride arm if they received any dose of Radium-223 dichloride, otherwise to the placebo arm.
According to protocol amendment 10, all participants who completed the EOT visit will be transferred to a separate extended safety follow-up study for their remaining follow-up. Thus, no further post-treatment data were collected after protocol amendment 10.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=139 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=139 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Number of Participants With Post-treatment Chemotherapy Related Adverse Events
All system organ classes_Any_Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Chemotherapy Related Adverse Events
All system organ classes_Any_Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Chemotherapy Related Adverse Events
Blood and lymphatic system disorders_Any_Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Chemotherapy Related Adverse Events
Blood and lymphatic system disorders_Febrile neutropenia_Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Chemotherapy Related Adverse Events
Investigations_Any_Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Chemotherapy Related Adverse Events
Investigations_Neutrophil count decreased_Grade 4
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dosing up to 30 days after the last administration of study treatments, up to 72.6 monthsPopulation: Safety analysis set with at least one hematology lab assessment: all randomized participants who received at least one dose of any study medication (radium 223 dichloride or placebo, exemestane, and everolimus), and who in addition had at least one hematology lab assessment. Participants were assigned to the Radium-223 dichloride arm if they received any dose of Radium-223 dichloride, otherwise to the placebo arm.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=139 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=137 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Anemia · Grade 1
|
61 Participants
|
57 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Anemia · Grade 2
|
43 Participants
|
55 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Anemia · Grade 3
|
21 Participants
|
11 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Anemia · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Anemia · Normal
|
14 Participants
|
14 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Leukocytosis · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Leukocytosis · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Leukocytosis · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Leukocytosis · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Leukocytosis · Normal
|
139 Participants
|
137 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Hemoglobin increased · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Hemoglobin increased · Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Hemoglobin increased · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Hemoglobin increased · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Hemoglobin increased · Normal
|
138 Participants
|
137 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Lymphocyte count decreased · Grade 1
|
20 Participants
|
33 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Lymphocyte count decreased · Grade 2
|
63 Participants
|
45 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Lymphocyte count decreased · Grade 3
|
43 Participants
|
24 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Lymphocyte count decreased · Grade 4
|
2 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Lymphocyte count decreased · Normal
|
11 Participants
|
35 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Lymphocyte count increased · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Lymphocyte count increased · Grade 2
|
2 Participants
|
2 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Lymphocyte count increased · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Lymphocyte count increased · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Lymphocyte count increased · Normal
|
137 Participants
|
135 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Neutrophil count decreased · Grade 1
|
23 Participants
|
30 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Neutrophil count decreased · Grade 2
|
48 Participants
|
28 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Neutrophil count decreased · Grade 3
|
19 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Neutrophil count decreased · Grade 4
|
0 Participants
|
2 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Platelet count decreased · Grade 1
|
60 Participants
|
60 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Platelet count decreased · Grade 2
|
7 Participants
|
3 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Platelet count decreased · Grade 3
|
7 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Platelet count decreased · Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Platelet count decreased · Normal
|
64 Participants
|
74 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
White blood cell decreased · Grade 1
|
37 Participants
|
48 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
White blood cell decreased · Grade 2
|
59 Participants
|
37 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
White blood cell decreased · Grade 3
|
17 Participants
|
3 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
White blood cell decreased · Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
White blood cell decreased · Normal
|
25 Participants
|
48 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment
Neutrophil count decreased · Normal
|
49 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: From first dosing till end of study, up to 72.6 monthsPopulation: Safety analysis set: all randomized participants who received at least one dose of any study medication (radium 223 dichloride or placebo, exemestane, and everolimus). Participants were assigned to the Radium-223 dichloride arm if they received any dose of Radium-223 dichloride, otherwise to the placebo arm.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=139 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=139 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Number of Participants With New Primary Malignancies
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first dosing till primary analysis cutoff date, up to 55 monthsPopulation: Safety analysis set: all randomized participants who received at least one dose of any study medication (radium 223 dichloride or placebo, exemestane, and everolimus). Participants were assigned to the Radium-223 dichloride arm if they received any dose of Radium-223 dichloride, otherwise to the placebo arm.
An AE was any untoward medical occurrence (i.e. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a patient or clinical investigation participant after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they started or worsened after first application of study intervention up to 30 days after end of treatment with study intervention. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly; another medical important serious event as judged by the investigator and an occurrence of any additional malignancies, including acute myelocytic leukemia or hematological conditions.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=139 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=139 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (From First Dosing Till Primary Analysis)
Any TEAE
|
139 Participants
|
136 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (From First Dosing Till Primary Analysis)
Serious TEAE
|
57 Participants
|
53 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (From First Dosing Till Primary Analysis)
Radium-223/Placebo-related TEAEs
|
73 Participants
|
50 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (From First Dosing Till Primary Analysis)
Exemestane-related TEAEs
|
75 Participants
|
64 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (From First Dosing Till Primary Analysis)
Everolimus-related TEAEs
|
130 Participants
|
125 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From post-treatment till primary analysis cutoff date, up to 55 monthsPopulation: Safety analysis set: all randomized participants who received at least one dose of any study medication (radium 223 dichloride or placebo, exemestane, and everolimus). Participants were assigned to the Radium-223 dichloride arm if they received any dose of Radium-223 dichloride, otherwise to the placebo arm.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=139 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=139 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Number of Participants With Post-treatment Chemotherapy Related Adverse Events (From First Dosing Till Primary Analysis)
All system organ classes_Any_Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Chemotherapy Related Adverse Events (From First Dosing Till Primary Analysis)
All system organ classes_Any_Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Chemotherapy Related Adverse Events (From First Dosing Till Primary Analysis)
Blood and lymphatic system disorders_Any_Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Chemotherapy Related Adverse Events (From First Dosing Till Primary Analysis)
Blood and lymphatic system disorders_Febrile neutropenia_Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Chemotherapy Related Adverse Events (From First Dosing Till Primary Analysis)
Investigations_Any_Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-treatment Chemotherapy Related Adverse Events (From First Dosing Till Primary Analysis)
Investigations_Neutrophil count decreased_Grade 4
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first dosing till primary analysis cutoff date, up to 55 monthsPopulation: Safety analysis set with at least one hematology lab assessment: all randomized participants who received at least one dose of any study medication (radium 223 dichloride or placebo, exemestane, and everolimus), and who in addition had at least one hematology lab assessment. Participants were assigned to the Radium-223 dichloride arm if they received any dose of Radium-223 dichloride, otherwise to the placebo arm.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=139 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=137 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Anemia · Grade 1
|
61 Participants
|
57 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Anemia · Grade 2
|
43 Participants
|
55 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Anemia · Grade 3
|
21 Participants
|
11 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Anemia · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Anemia · Normal
|
14 Participants
|
14 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Leukocytosis · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Leukocytosis · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Leukocytosis · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Leukocytosis · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Leukocytosis · Normal
|
139 Participants
|
137 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Hemoglobin increased · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Hemoglobin increased · Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Hemoglobin increased · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Hemoglobin increased · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Hemoglobin increased · Normal
|
138 Participants
|
137 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Lymphocyte count decreased · Grade 1
|
20 Participants
|
33 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Lymphocyte count decreased · Grade 2
|
63 Participants
|
45 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Lymphocyte count decreased · Grade 3
|
43 Participants
|
24 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Lymphocyte count decreased · Grade 4
|
2 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Lymphocyte count decreased · Normal
|
11 Participants
|
35 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Lymphocyte count increased · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Lymphocyte count increased · Grade 2
|
2 Participants
|
2 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Lymphocyte count increased · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Lymphocyte count increased · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Lymphocyte count increased · Normal
|
137 Participants
|
135 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Neutrophil count decreased · Grade 1
|
24 Participants
|
29 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Neutrophil count decreased · Grade 2
|
47 Participants
|
28 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Neutrophil count decreased · Grade 3
|
19 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Neutrophil count decreased · Grade 4
|
0 Participants
|
2 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Neutrophil count decreased · Normal
|
49 Participants
|
78 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Platelet count decreased · Grade 1
|
60 Participants
|
61 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Platelet count decreased · Grade 2
|
7 Participants
|
2 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Platelet count decreased · Grade 3
|
7 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Platelet count decreased · Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
Platelet count decreased · Normal
|
64 Participants
|
74 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
White blood cell decreased · Grade 1
|
37 Participants
|
47 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
White blood cell decreased · Grade 2
|
59 Participants
|
36 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
White blood cell decreased · Grade 3
|
17 Participants
|
3 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
White blood cell decreased · Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With Hematological Toxicities: Worst Grade Under Treatment (From First Dosing Till Primary Analysis)
White blood cell decreased · Normal
|
25 Participants
|
50 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first dosing till primary analysis cutoff date, up to 55 monthsPopulation: Safety analysis set: all randomized participants who received at least one dose of any study medication (radium 223 dichloride or placebo, exemestane, and everolimus). Participants were assigned to the Radium-223 dichloride arm if they received any dose of Radium-223 dichloride, otherwise to the placebo arm.
Outcome measures
| Measure |
Radium-223 + EXE/EVE
n=139 Participants
Participants randomized to treatment with radium-223 dichloride, 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=139 Participants
Participants randomized to treatment with placebo, also received exemestane (EXE), 25-mg tablet once daily (after a meal), and everolimus (EVE), 10 mg once daily (with or without food), and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Number of Participants With New Primary Malignancies During Study Treatment Till Primary Analysis
|
1 Participants
|
0 Participants
|
Adverse Events
Radium-223 + EXE/EVE
Serious events: 61 serious events
Other events: 139 other events
Deaths: 66 deaths
Placebo + EXE/EVE
Serious events: 56 serious events
Other events: 135 other events
Deaths: 67 deaths
Serious adverse events
| Measure |
Radium-223 + EXE/EVE
n=139 participants at risk
Participants were randomized to treatment with radium-223 dichloride, also with exemestane and everolimus and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=139 participants at risk
Participants were randomized to treatment with placebo, also with exemestane and everolimus and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Gastrointestinal disorders
Stomatitis
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
2/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
1.4%
2/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Death
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
1.4%
2/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Fatigue
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Injection site extravasation
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Malaise
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Oedema peripheral
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
1.4%
2/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Pain
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Pyrexia
|
1.4%
2/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
2.2%
3/139 • Number of events 5 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Sudden death
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Performance status decreased
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
General physical health deterioration
|
1.4%
2/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
2.2%
3/139 • Number of events 4 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Hepatobiliary disorders
Hepatic haematoma
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Appendicitis
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Cellulitis
|
1.4%
2/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Erysipelas
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
2/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Influenza
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Labyrinthitis
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Pneumonia
|
3.6%
5/139 • Number of events 6 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
2.9%
4/139 • Number of events 5 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Sepsis
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Sinusitis
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Skin infection
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Urinary tract infection
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
1.4%
2/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Vestibular neuronitis
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Wound infection
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Febrile infection
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Investigations
Biopsy lung
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Investigations
Influenza A virus test positive
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
1.4%
2/139 • Number of events 4 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
1.4%
2/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
2/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
1.4%
2/139 • Number of events 5 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
2.2%
3/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
2.9%
4/139 • Number of events 4 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.4%
2/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to ovary
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
1.4%
2/139 • Number of events 4 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendix cancer metastatic
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Dizziness
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Headache
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Paraparesis
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Spinal cord compression
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Neurological decompensation
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Medullary compression syndrome
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.72%
1/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
2.2%
3/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
3.6%
5/139 • Number of events 8 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
7/139 • Number of events 11 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
1.4%
2/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
2/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
3/139 • Number of events 6 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
3.6%
5/139 • Number of events 12 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
2/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.72%
1/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Cardiac disorders
Atrial fibrillation
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
1.4%
2/139 • Number of events 2 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
3/139 • Number of events 6 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Enteritis
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Nausea
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/139 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
Other adverse events
| Measure |
Radium-223 + EXE/EVE
n=139 participants at risk
Participants were randomized to treatment with radium-223 dichloride, also with exemestane and everolimus and supportive care as per the local or institutional standard of practice
|
Placebo + EXE/EVE
n=139 participants at risk
Participants were randomized to treatment with placebo, also with exemestane and everolimus and supportive care as per the local or institutional standard of practice
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
39.6%
55/139 • Number of events 191 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
28.8%
40/139 • Number of events 146 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.6%
12/139 • Number of events 49 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
1.4%
2/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.9%
29/139 • Number of events 73 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
7.9%
11/139 • Number of events 11 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.1%
21/139 • Number of events 58 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
6.5%
9/139 • Number of events 19 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Ear and labyrinth disorders
Vertigo
|
5.8%
8/139 • Number of events 10 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
0.72%
1/139 • Number of events 1 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
7/139 • Number of events 7 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
7.9%
11/139 • Number of events 13 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.8%
15/139 • Number of events 18 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
5.0%
7/139 • Number of events 8 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
6/139 • Number of events 7 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
14.4%
20/139 • Number of events 23 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.2%
42/139 • Number of events 66 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
22.3%
31/139 • Number of events 54 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Dry mouth
|
7.2%
10/139 • Number of events 13 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
6.5%
9/139 • Number of events 9 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
7/139 • Number of events 8 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
5.0%
7/139 • Number of events 8 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.2%
3/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
7.2%
10/139 • Number of events 19 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Nausea
|
29.5%
41/139 • Number of events 55 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
21.6%
30/139 • Number of events 42 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Stomatitis
|
47.5%
66/139 • Number of events 144 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
49.6%
69/139 • Number of events 172 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Gastrointestinal disorders
Vomiting
|
18.0%
25/139 • Number of events 32 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
15.8%
22/139 • Number of events 31 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Asthenia
|
20.9%
29/139 • Number of events 48 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
18.7%
26/139 • Number of events 52 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Fatigue
|
27.3%
38/139 • Number of events 66 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
29.5%
41/139 • Number of events 60 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Oedema peripheral
|
18.7%
26/139 • Number of events 37 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
18.0%
25/139 • Number of events 34 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Pyrexia
|
14.4%
20/139 • Number of events 27 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
9.4%
13/139 • Number of events 16 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
General disorders
Peripheral swelling
|
5.8%
8/139 • Number of events 8 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
7.2%
10/139 • Number of events 17 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Conjunctivitis
|
5.8%
8/139 • Number of events 8 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
2.2%
3/139 • Number of events 3 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Cystitis
|
2.9%
4/139 • Number of events 4 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
5.0%
7/139 • Number of events 8 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
7/139 • Number of events 7 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
3.6%
5/139 • Number of events 7 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.8%
15/139 • Number of events 22 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
14.4%
20/139 • Number of events 38 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Infections and infestations
Urinary tract infection
|
8.6%
12/139 • Number of events 16 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
8.6%
12/139 • Number of events 14 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Investigations
Alanine aminotransferase increased
|
15.1%
21/139 • Number of events 51 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
16.5%
23/139 • Number of events 52 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Investigations
Aspartate aminotransferase increased
|
13.7%
19/139 • Number of events 44 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
15.1%
21/139 • Number of events 40 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Investigations
Blood cholesterol increased
|
10.8%
15/139 • Number of events 22 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
7.2%
10/139 • Number of events 22 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Investigations
Blood creatinine increased
|
7.9%
11/139 • Number of events 26 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
7.2%
10/139 • Number of events 23 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Investigations
Lymphocyte count decreased
|
5.8%
8/139 • Number of events 36 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
5.0%
7/139 • Number of events 14 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Investigations
Neutrophil count decreased
|
10.1%
14/139 • Number of events 43 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
4.3%
6/139 • Number of events 11 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Investigations
Platelet count decreased
|
8.6%
12/139 • Number of events 42 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
8.6%
12/139 • Number of events 28 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Investigations
Weight decreased
|
20.1%
28/139 • Number of events 37 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
15.8%
22/139 • Number of events 31 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Investigations
White blood cell count decreased
|
9.4%
13/139 • Number of events 43 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
9.4%
13/139 • Number of events 31 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
8.6%
12/139 • Number of events 28 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
4.3%
6/139 • Number of events 9 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.2%
17/139 • Number of events 36 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
12.9%
18/139 • Number of events 41 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
8.6%
12/139 • Number of events 29 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
7.9%
11/139 • Number of events 38 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.9%
4/139 • Number of events 4 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
5.8%
8/139 • Number of events 14 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.7%
19/139 • Number of events 29 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
10.1%
14/139 • Number of events 27 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.9%
11/139 • Number of events 16 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
5.8%
8/139 • Number of events 37 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
34.5%
48/139 • Number of events 68 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
25.2%
35/139 • Number of events 43 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.6%
30/139 • Number of events 51 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
30.2%
42/139 • Number of events 81 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
16/139 • Number of events 17 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
18.7%
26/139 • Number of events 36 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.5%
16/139 • Number of events 31 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
17.3%
24/139 • Number of events 34 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
4/139 • Number of events 4 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
5.8%
8/139 • Number of events 10 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
9/139 • Number of events 10 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
5.0%
7/139 • Number of events 8 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.1%
21/139 • Number of events 28 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
18.0%
25/139 • Number of events 37 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
11.5%
16/139 • Number of events 22 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
10.8%
15/139 • Number of events 23 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.3%
6/139 • Number of events 7 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
8.6%
12/139 • Number of events 15 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
6.5%
9/139 • Number of events 12 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
1.4%
2/139 • Number of events 4 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
5.0%
7/139 • Number of events 10 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
6.5%
9/139 • Number of events 13 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Dizziness
|
6.5%
9/139 • Number of events 11 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
6.5%
9/139 • Number of events 12 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Dysgeusia
|
12.2%
17/139 • Number of events 26 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
9.4%
13/139 • Number of events 14 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Nervous system disorders
Headache
|
18.0%
25/139 • Number of events 35 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
21.6%
30/139 • Number of events 42 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Psychiatric disorders
Insomnia
|
10.8%
15/139 • Number of events 15 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
10.1%
14/139 • Number of events 16 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.0%
25/139 • Number of events 37 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
18.7%
26/139 • Number of events 40 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.5%
16/139 • Number of events 20 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
12.2%
17/139 • Number of events 25 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.5%
9/139 • Number of events 12 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
10.1%
14/139 • Number of events 15 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.5%
16/139 • Number of events 20 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
11.5%
16/139 • Number of events 19 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
7/139 • Number of events 8 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
5.8%
8/139 • Number of events 10 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.0%
7/139 • Number of events 11 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
6.5%
9/139 • Number of events 31 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.8%
8/139 • Number of events 8 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
10.1%
14/139 • Number of events 15 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.2%
17/139 • Number of events 18 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
10.1%
14/139 • Number of events 20 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.4%
20/139 • Number of events 29 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
21.6%
30/139 • Number of events 44 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.5%
9/139 • Number of events 11 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
5.0%
7/139 • Number of events 14 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
|
Vascular disorders
Hypertension
|
9.4%
13/139 • Number of events 22 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
5.0%
7/139 • Number of events 11 • Time Frame for AE: After providing written informed consent for participation in the study till end of study, up to 73.5 months. Time Frame for the all-cause mortality: Considers all deaths that occurred at any time during the study of 17096 before the last contact, up to 73.5 months.
For All-Cause Mortality section, "Total Number Affected" are updated in final results posting. Deaths of this study 17096 participants who transferred to study 16996 (NCT02312960) for long-term follow-up were erroneously reported in the 17096 primary analysis disclosure. This has been corrected and only 17096 data is reported in this disclosure here. 16996 outcomes will be reported in the 16996 disclosure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Where done for the purpose of filing a patent application, and where deemed necessary, the Sponsor/Bayer may request the PI of the Trial to postpone by 90 days the publication or presentation of a paper. The PI of the Trial may not publish the data yielded by its Site until all the results of the trial (in the case of a multi-center trial) have been published in their entirety or until at least 12 months have passed following completion, discontinuation or early termination of the Trial.
- Publication restrictions are in place
Restriction type: OTHER