Trial Outcomes & Findings for Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients (NCT NCT01526928)
NCT ID: NCT01526928
Last Updated: 2020-08-04
Results Overview
Percentage of patients with a T790M mutation (determined by central lab) with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
612 participants
Primary outcome timeframe
Cycle 1 Day 1 to End of Treatment, up to approximately 42 months
Results posted on
2020-08-04
Participant Flow
There were 612 patients who received rociletinib-111 enrolled in Phase 1 and 501 enrolled in Phase 2. The Phase 1 component of the study was conducted at 8 study sites in the US, Australia, and France. Phase 2 was conducted at 49 study sites in the US, France, Poland, and Australia.
Participant milestones
| Measure |
Rociletinib <900 mg BID FB Capsules
Rociletinib free base (FB) dose \<900 mg twice a day (BID). FB doses tested ranged from 150 mg once a day (QD) up to 900 mg twice a day (BID). This arm also includes a 400 mg three times a day (TID) dose. Rociletinib FB capsules were administered in Phase 1 only (until November 2013) and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day treatment cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID). Rociletinib FB capsules were administered in Phase 1 only (until November 2013) and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day treatment cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
38
|
19
|
209
|
245
|
95
|
6
|
|
Overall Study
Started Phase 1
|
38
|
19
|
18
|
17
|
13
|
6
|
|
Overall Study
Started Phase 2
|
0
|
0
|
191
|
228
|
82
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
38
|
19
|
209
|
245
|
95
|
6
|
Reasons for withdrawal
| Measure |
Rociletinib <900 mg BID FB Capsules
Rociletinib free base (FB) dose \<900 mg twice a day (BID). FB doses tested ranged from 150 mg once a day (QD) up to 900 mg twice a day (BID). This arm also includes a 400 mg three times a day (TID) dose. Rociletinib FB capsules were administered in Phase 1 only (until November 2013) and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day treatment cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID). Rociletinib FB capsules were administered in Phase 1 only (until November 2013) and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day treatment cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.
|
|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
35
|
17
|
150
|
182
|
76
|
4
|
|
Overall Study
Adverse Event
|
2
|
1
|
29
|
40
|
13
|
2
|
|
Overall Study
Death
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
13
|
11
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
5
|
0
|
0
|
|
Overall Study
Other Reason
|
0
|
1
|
11
|
4
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Missing
|
0
|
0
|
1
|
0
|
2
|
0
|
Baseline Characteristics
Data not available for one participant in the 500 mg BID Hbr treatment group.
Baseline characteristics by cohort
| Measure |
Rociletinib <900 mg BID FB Capsules
n=38 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=19 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=209 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=245 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=95 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=6 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Total
n=612 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 11.54 • n=38 Participants
|
58.9 years
STANDARD_DEVIATION 8.37 • n=19 Participants
|
63.6 years
STANDARD_DEVIATION 11.45 • n=209 Participants
|
62.5 years
STANDARD_DEVIATION 11.14 • n=245 Participants
|
61.5 years
STANDARD_DEVIATION 11.82 • n=95 Participants
|
65.2 years
STANDARD_DEVIATION 5.53 • n=6 Participants
|
62.5 years
STANDARD_DEVIATION 11.29 • n=612 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=38 Participants
|
15 Participants
n=19 Participants
|
155 Participants
n=209 Participants
|
155 Participants
n=245 Participants
|
63 Participants
n=95 Participants
|
5 Participants
n=6 Participants
|
424 Participants
n=612 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=38 Participants
|
4 Participants
n=19 Participants
|
54 Participants
n=209 Participants
|
90 Participants
n=245 Participants
|
32 Participants
n=95 Participants
|
1 Participants
n=6 Participants
|
188 Participants
n=612 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=38 Participants
|
2 Participants
n=19 Participants
|
5 Participants
n=209 Participants
|
14 Participants
n=245 Participants
|
2 Participants
n=95 Participants
|
0 Participants
n=6 Participants
|
25 Participants
n=612 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=38 Participants
|
15 Participants
n=19 Participants
|
170 Participants
n=209 Participants
|
184 Participants
n=245 Participants
|
90 Participants
n=95 Participants
|
6 Participants
n=6 Participants
|
495 Participants
n=612 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=38 Participants
|
2 Participants
n=19 Participants
|
34 Participants
n=209 Participants
|
47 Participants
n=245 Participants
|
3 Participants
n=95 Participants
|
0 Participants
n=6 Participants
|
92 Participants
n=612 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=38 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=209 Participants
|
1 Participants
n=245 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=612 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=38 Participants
|
4 Participants
n=19 Participants
|
41 Participants
n=209 Participants
|
49 Participants
n=245 Participants
|
24 Participants
n=95 Participants
|
1 Participants
n=6 Participants
|
124 Participants
n=612 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=38 Participants
|
0 Participants
n=19 Participants
|
4 Participants
n=209 Participants
|
3 Participants
n=245 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=6 Participants
|
7 Participants
n=612 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=38 Participants
|
0 Participants
n=19 Participants
|
7 Participants
n=209 Participants
|
8 Participants
n=245 Participants
|
2 Participants
n=95 Participants
|
0 Participants
n=6 Participants
|
17 Participants
n=612 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=38 Participants
|
13 Participants
n=19 Participants
|
122 Participants
n=209 Participants
|
137 Participants
n=245 Participants
|
64 Participants
n=95 Participants
|
5 Participants
n=6 Participants
|
368 Participants
n=612 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=38 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=209 Participants
|
1 Participants
n=245 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=612 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=38 Participants
|
2 Participants
n=19 Participants
|
35 Participants
n=209 Participants
|
46 Participants
n=245 Participants
|
5 Participants
n=95 Participants
|
0 Participants
n=6 Participants
|
94 Participants
n=612 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=38 Participants
|
13 Participants
n=19 Participants
|
122 Participants
n=209 Participants
|
137 Participants
n=245 Participants
|
64 Participants
n=95 Participants
|
5 Participants
n=6 Participants
|
368 Participants
n=612 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=38 Participants
|
0 Participants
n=19 Participants
|
7 Participants
n=209 Participants
|
8 Participants
n=245 Participants
|
2 Participants
n=95 Participants
|
0 Participants
n=6 Participants
|
17 Participants
n=612 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=38 Participants
|
4 Participants
n=19 Participants
|
41 Participants
n=209 Participants
|
49 Participants
n=245 Participants
|
24 Participants
n=95 Participants
|
1 Participants
n=6 Participants
|
124 Participants
n=612 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=38 Participants
|
2 Participants
n=19 Participants
|
39 Participants
n=209 Participants
|
51 Participants
n=245 Participants
|
5 Participants
n=95 Participants
|
0 Participants
n=6 Participants
|
103 Participants
n=612 Participants
|
|
Time Since Diagnosis of NSCLC (months)
|
40.4 Months
STANDARD_DEVIATION 29.2 • n=38 Participants • Data not available for one participant in the 500 mg BID Hbr treatment group.
|
45.4 Months
STANDARD_DEVIATION 31.94 • n=19 Participants • Data not available for one participant in the 500 mg BID Hbr treatment group.
|
36.7 Months
STANDARD_DEVIATION 25.81 • n=208 Participants • Data not available for one participant in the 500 mg BID Hbr treatment group.
|
36.7 Months
STANDARD_DEVIATION 31.41 • n=245 Participants • Data not available for one participant in the 500 mg BID Hbr treatment group.
|
37.6 Months
STANDARD_DEVIATION 29.97 • n=95 Participants • Data not available for one participant in the 500 mg BID Hbr treatment group.
|
47.4 Months
STANDARD_DEVIATION 27.03 • n=6 Participants • Data not available for one participant in the 500 mg BID Hbr treatment group.
|
37.4 Months
STANDARD_DEVIATION 29.17 • n=611 Participants • Data not available for one participant in the 500 mg BID Hbr treatment group.
|
|
T790M Status ( Determined by Central Lab)
Negative
|
5 Participants
n=38 Participants
|
4 Participants
n=19 Participants
|
6 Participants
n=209 Participants
|
25 Participants
n=245 Participants
|
9 Participants
n=95 Participants
|
0 Participants
n=6 Participants
|
49 Participants
n=612 Participants
|
|
T790M Status ( Determined by Central Lab)
Positive
|
23 Participants
n=38 Participants
|
9 Participants
n=19 Participants
|
188 Participants
n=209 Participants
|
176 Participants
n=245 Participants
|
80 Participants
n=95 Participants
|
4 Participants
n=6 Participants
|
480 Participants
n=612 Participants
|
|
T790M Status ( Determined by Central Lab)
Unknown
|
10 Participants
n=38 Participants
|
6 Participants
n=19 Participants
|
4 Participants
n=209 Participants
|
1 Participants
n=245 Participants
|
1 Participants
n=95 Participants
|
2 Participants
n=6 Participants
|
24 Participants
n=612 Participants
|
|
T790M Status ( Determined by Central Lab)
Missing
|
0 Participants
n=38 Participants
|
0 Participants
n=19 Participants
|
11 Participants
n=209 Participants
|
43 Participants
n=245 Participants
|
5 Participants
n=95 Participants
|
0 Participants
n=6 Participants
|
59 Participants
n=612 Participants
|
|
History of CNS Metastases
|
20 Participants
n=38 Participants
|
7 Participants
n=19 Participants
|
86 Participants
n=209 Participants
|
107 Participants
n=245 Participants
|
44 Participants
n=95 Participants
|
3 Participants
n=6 Participants
|
267 Participants
n=612 Participants
|
|
Number of Previous Therapies
|
3.8 Therapies
STANDARD_DEVIATION 1.65 • n=38 Participants
|
3.7 Therapies
STANDARD_DEVIATION 1.66 • n=19 Participants
|
2.6 Therapies
STANDARD_DEVIATION 1.74 • n=209 Participants
|
2.8 Therapies
STANDARD_DEVIATION 1.91 • n=245 Participants
|
2.9 Therapies
STANDARD_DEVIATION 2.11 • n=95 Participants
|
3.8 Therapies
STANDARD_DEVIATION 2.04 • n=6 Participants
|
2.9 Therapies
STANDARD_DEVIATION 1.88 • n=612 Participants
|
|
Number of Previous TKI Therapies
|
1.7 Therapies
STANDARD_DEVIATION 0.77 • n=38 Participants
|
2.3 Therapies
STANDARD_DEVIATION 1.48 • n=19 Participants
|
1.5 Therapies
STANDARD_DEVIATION 0.87 • n=209 Participants
|
1.6 Therapies
STANDARD_DEVIATION 0.77 • n=245 Participants
|
1.6 Therapies
STANDARD_DEVIATION 0.86 • n=95 Participants
|
1.8 Therapies
STANDARD_DEVIATION 0.75 • n=6 Participants
|
1.6 Therapies
STANDARD_DEVIATION 0.86 • n=612 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 to End of Treatment, up to approximately 42 monthsPopulation: Intent-to-treat: All randomized patients who are confirmed by central lab to be T790M positive
Percentage of patients with a T790M mutation (determined by central lab) with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=23 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=9 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=188 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=176 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=80 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=4 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of T790M Positive Patients With Confirmed Response Per Investigator
|
0 Participants
|
3 Participants
|
54 Participants
|
72 Participants
|
23 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 to End of Treatment, up to approximately 36 monthsPopulation: The DOR was measured only in T790M positive patients with a Complete Response (CR) or Partial Response (PR). There were no responders in the Rociletinib \<900 mg BID treatment group so DOR is not applicable and thus not reported.
Duration of Response in patients with a T790M mutation (determined by central lab) with confirmed response per investigator. The DOR for complete response (CR) and partial response (PR) was measured from the date that any of these best responses is first recorded until the first date that progressive disease (PD) is objectively documented. For patients who continue treatment post-progression, the first date of progression was used for the analysis.
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=54 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=72 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=23 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) in T790M Positive Patients According to RECIST Version 1.1 as Determined by Investigator Assessment
|
329.0 Days
Interval 190.0 to 713.0
|
275.0 Days
Interval 226.0 to 336.0
|
274.0 Days
Interval 169.0 to 337.0
|
217.0 Days
Interval 146.0 to 340.0
|
428 Days
There are an insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 to Cycle 1 Day 21Population: The dose limiting toxicity (DLT) evaluable population includes all patients who have completed Cycle 1, and who were enrolled while the dose escalation (Phase 1) part of the study was ongoing.
The number of Phase 1 patients who experienced dose limiting toxicities after one cycle (21 days) of study drug.
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=24 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=6 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=6 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=8 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=9 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=6 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT) Incidence
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 to date of death, assessed up to 42 monthsPopulation: The overall number of patients analyzed contains centrally determined T790M positive patients only. There are 2 less patients in the \<900 mg BID FB group, and 1 less patient in each of the 500, 625 and 750 mg BID dose groups because they were not followed for OS.
Overall survival was calculated as 1+ the number of days from the first dose of study drug to death due to any cause. Patients without a documented date of death were censored on the date the patient was last known to be alive.
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=21 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=9 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=187 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=175 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=79 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=4 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) Determined by Investigator Assessment
|
16.3 months
Interval 6.3 to 17.9
|
23.7 months
Interval 1.4 to
There are an insufficient number of participants with events.
|
18.5 months
Interval 13.0 to
There are an insufficient number of participants with events.
|
15.0 months
Interval 12.5 to 17.3
|
12.9 months
Interval 9.9 to 17.7
|
7.2 months
Interval 2.2 to
There are an insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 to End of Treatment, up to approximately 42 monthsPopulation: The overall number of patients analyzed contains centrally determined T790M positive patients only. There are 2 less patients in the \<900 mg BID FB group, and 1 less patient in each of the 500 and 625 mg BID dose groups because they were not followed for PFS.
Progression-free survival was calculated as the number of days from the date of the first dose of study drug to the date of disease progression or death due to any cause + 1. Patients without a documented event of disease progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment) or date of first dose of study drug if no tumor assessments have been performed. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=21 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=9 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=187 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=175 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=80 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=4 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
|
2.6 months
Interval 1.3 to 4.0
|
10.4 months
Interval 1.4 to 12.2
|
5.7 months
Interval 4.2 to 6.2
|
5.2 months
Interval 4.1 to 6.2
|
4.3 months
Interval 2.9 to 6.1
|
7.2 months
Interval 2.2 to 16.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 daysPopulation: PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point.
Cmax = maximum concentration following administration of rociletinib
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=9 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
n=5 Participants
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=19 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
n=18 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=21 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=23 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=6 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Profile of Rociletinib - Cmax
Day 1 Cmax
|
537 ng/mL
Standard Deviation 71
|
533 ng/mL
Standard Deviation 63
|
1290 ng/mL
Standard Deviation 1019
|
1800 ng/mL
Standard Deviation 1224
|
969 ng/mL
Standard Deviation 824
|
2470 ng/mL
Standard Deviation 1482
|
574 ng/mL
Standard Deviation 293
|
706 ng/mL
Standard Deviation 88
|
1680 ng/mL
Standard Deviation 1126
|
1650 ng/mL
Standard Deviation 809
|
704 ng/mL
Standard Deviation 352
|
2800 ng/mL
Standard Deviation 2128
|
2980 ng/mL
Standard Deviation 2235
|
2570 ng/mL
Standard Deviation 1850
|
4250 ng/mL
Standard Deviation 2678
|
|
PK Profile of Rociletinib - Cmax
Day 15 Cmax
|
250 ng/mL
Standard Deviation 188
|
503 ng/mL
Standard Deviation 377
|
1760 ng/mL
Standard Deviation 1056
|
942 ng/mL
Standard Deviation 857
|
981 ng/mL
Standard Deviation 343
|
2200 ng/mL
Standard Deviation 1100
|
729 ng/mL
Standard Deviation 576
|
647 ng/mL
Standard Deviation 304
|
928 ng/mL
Standard Deviation 95
|
1510 ng/mL
Standard Deviation 997
|
1140 ng/mL
Standard Deviation 274
|
2330 ng/mL
Standard Deviation 1375
|
3070 ng/mL
Standard Deviation 2272
|
2100 ng/mL
Standard Deviation 1029
|
2510 ng/mL
Standard Deviation 728
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 daysPopulation: PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point.
Tmax = time to maximum concentration following administration of rociletinib
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=9 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
n=5 Participants
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=19 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
n=18 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=21 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=23 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=6 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Profile of Rociletinib - Tmax
Day 1 Tmax
|
1.5 Hours
Interval 1.0 to 2.5
|
2.5 Hours
Interval 1.0 to 2.5
|
2.5 Hours
Interval 1.5 to 6.0
|
1.5 Hours
Interval 1.5 to 2.5
|
2.0 Hours
Interval 1.5 to 2.5
|
2.5 Hours
Interval 2.5 to 4.0
|
2.5 Hours
Interval 2.5 to 4.0
|
4.0 Hours
Interval 4.0 to 8.0
|
4.0 Hours
Interval 2.5 to 6.0
|
4.0 Hours
Interval 1.0 to 8.0
|
2.5 Hours
Interval 1.0 to 10.0
|
1.5 Hours
Interval 0.5 to 10.0
|
2.5 Hours
Interval 1.0 to 8.0
|
2.5 Hours
Interval 1.0 to 8.0
|
3.25 Hours
Interval 1.0 to 4.0
|
|
PK Profile of Rociletinib - Tmax
Day 15 Tmax
|
2.0 Hours
Interval 1.0 to 4.0
|
1.5 Hours
Interval 1.5 to 2.5
|
2.5 Hours
Interval 2.5 to 4.0
|
1.5 Hours
Interval 1.5 to 2.5
|
2.5 Hours
Interval 1.5 to 6.0
|
4.0 Hours
Interval 1.5 to 4.0
|
2.5 Hours
Interval 1.5 to 2.5
|
1.5 Hours
Interval 1.0 to 6.0
|
2.5 Hours
Interval 2.5 to 4.0
|
4 Hours
Interval 0.0 to 8.0
|
10 Hours
Interval 10.0 to 10.0
|
2.5 Hours
Interval 1.0 to 8.0
|
2.5 Hours
Interval 1.0 to 6.0
|
2.5 Hours
Interval 1.0 to 8.0
|
1.5 Hours
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 daysPopulation: PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point. AUC was not calculated for patients in the 400 mg TID treatment group.
AUC 0-24 = area under the curve from 0 to 24 hours
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=9 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
n=5 Participants
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=19 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
n=18 Participants
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
n=21 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=23 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=6 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Profile of Rociletinib - AUC 0-24
Day 1 AUC 0-24
|
2900 ng*hr/mL
Standard Deviation 290
|
5330 ng*hr/mL
Standard Deviation 5880
|
8370 ng*hr/mL
Standard Deviation 6612
|
8850 ng*hr/mL
Standard Deviation 6461
|
5840 ng*hr/mL
Standard Deviation 3387
|
13300 ng*hr/mL
Standard Deviation 6650
|
5740 ng*hr/mL
Standard Deviation 2927
|
8470 ng*hr/mL
Standard Deviation 1008
|
20400 ng*hr/mL
Standard Deviation 12444
|
16000 ng*hr/mL
Standard Deviation 8960
|
26800 ng*hr/mL
Standard Deviation 13668
|
33100 ng*hr/mL
Standard Deviation 26149
|
30300 ng*hr/mL
Standard Deviation 16968
|
50100 ng*hr/mL
Standard Deviation 35070
|
—
|
|
PK Profile of Rociletinib - AUC 0-24
Day 15 AUC 0-24
|
1540 ng*hr/mL
Standard Deviation 970
|
3510 ng*hr/mL
Standard Deviation 2620
|
12100 ng*hr/mL
Standard Deviation 11616
|
4490 ng*hr/mL
Standard Deviation 3817
|
4800 ng*hr/mL
Standard Deviation 2256
|
11500 ng*hr/mL
Standard Deviation 6555
|
7100 ng*hr/mL
Standard Deviation 4189
|
6080 ng*hr/mL
Standard Deviation 4560
|
12100 ng*hr/mL
Standard Deviation 1404
|
17500 ng*hr/mL
Standard Deviation 10675
|
23700 ng*hr/mL
Standard Deviation 13035
|
31700 ng*hr/mL
Standard Deviation 18386
|
25800 ng*hr/mL
Standard Deviation 14190
|
28200 ng*hr/mL
Standard Deviation 16638
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 daysPopulation: PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point. Elimination half-life was not calculated for patients in the 400 mg TID treatment group.
T 1/2 = elimination half-life following administration of rociletinib
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=9 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=3 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
n=5 Participants
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=19 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
n=18 Participants
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
n=21 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=23 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=6 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Profile of Rociletinib - T 1/2
Day 1 T 1/2
|
4.8 Hours
Standard Deviation 3.6
|
3.9 Hours
Standard Deviation 2.3
|
4.6 Hours
Standard Deviation 1.7
|
3.7 Hours
Standard Deviation 1.1
|
4.4 Hours
Standard Deviation 0.9
|
3.5 Hours
Standard Deviation 2.8
|
3.0 Hours
Standard Deviation 0.8
|
3.5 Hours
Standard Deviation 1.0
|
3.6 Hours
Standard Deviation 0.9
|
2.8 Hours
Standard Deviation 0.7
|
2.7 Hours
Standard Deviation 0.7
|
3.5 Hours
Standard Deviation 1.5
|
3.1 Hours
Standard Deviation 1.5
|
3.4 Hours
Standard Deviation 0.9
|
—
|
|
PK Profile of Rociletinib - T 1/2
Day 15 T 1/2
|
5.5 Hours
Standard Deviation 3.1
|
3.5 Hours
Standard Deviation 1.3
|
4.3 Hours
Standard Deviation 1.2
|
3.9 Hours
Standard Deviation 2.5
|
4.1 Hours
Standard Deviation 2.2
|
3.5 Hours
Standard Deviation .56
|
3.1 Hours
Standard Deviation 0.9
|
2.9 Hours
Standard Deviation 0.7
|
4.7 Hours
Standard Deviation 3.4
|
2.7 Hours
Standard Deviation 1.9
|
3.0 Hours
Standard Deviation 1.6
|
3.2 Hours
Standard Deviation 0.8
|
3.6 Hours
Standard Deviation 3.1
|
3.9 Hours
Standard Deviation 1.9
|
—
|
SECONDARY outcome
Timeframe: Day -7 prior to Cycle 1 Day 1, or approximately 7 daysPopulation: A subset of 3 patients treated with rociletinib 150 mg FB capsules
Cmax = maximum concentration following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Food Effect on PK of Rociletinib - Cmax
|
727 ng/mL
Standard Deviation 354
|
1873 ng/mL
Standard Deviation 2570
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -7 prior to Cycle 1 Day 1, or approximately 7 daysPopulation: A subset of 3 patients treated with rociletinib 150 mg FB capsules
Tmax = time to maximum concentration following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Food Effect on PK of Rociletinib - Tmax
|
1.5 Hours
Interval 1.0 to 2.5
|
4.8 Hours
Interval 2.5 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -7 prior to Cycle 1 Day 1, or approximately 7 daysPopulation: A subset of 3 patients treated with rociletinib 150 mg FB capsules. AUC could not be determined for 1 patient in the Fed arm.
AUC 0-24 = area under the curve from 0 to 24 hours. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=2 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Food Effect on PK of Rociletinib - AUC 0-24
|
4780 ng*hr/mL
Standard Deviation 3625
|
4455 ng*hr/mL
Standard Deviation 2256
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -7 prior to Cycle 1 Day 1, or approximately 7 daysPopulation: A subset of 3 patients treated with rociletinib 150 mg FB capsules
C24 = rociletinib plasma concentration at 24 hours post the morning dose. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Food Effect on PK of Rociletinib - C24
|
21.3 ng/mL
Standard Deviation 22
|
46.5 ng/mL
Standard Deviation 51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -7 prior to Cycle 1 Day 1, or approximately 7 daysPopulation: A subset of 3 patients treated with rociletinib 150 mg FB capsules. Data did not allow the calculation of half-life with high fat mean in 2 patients.
T 1/2 = elimination half-life following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=3 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=1 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Food Effect on PK of Rociletinib - T 1/2
|
4.3 Hours
Standard Deviation 1
|
3.1 Hours
Standard Deviation NA
Data for one patient only so standard deviation not applicable.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening to End of Treatment, up to approximately 42 monthsPopulation: Safety population by daily dose
Frequency of QT interval prolongation by daily dose (corrected using Fridericia's method, QTcF). To evaluate the effects of rociletinib on the QT (interval from Q wave to T wave)/QTc (interval corrected for heart rate) interval, all patients underwent serial ECG monitoring at Baseline, on Cycle 1 Day 1, Cycle 1 Day 15, on Day 1 of all subsequent cycles, at the EOT Visit, and as clinically indicated. Worst post-baseline QTcF value was used to categorize each patient.
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=38 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=19 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=209 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=245 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=95 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=6 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
QTcF Values Post Baseline by Daily Dose
QTcF Post-Baseline <450 msec
|
34 Participants
|
10 Participants
|
93 Participants
|
99 Participants
|
35 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
QTcF Values Post Baseline by Daily Dose
QTcF Post-Baseline 450-480 msec
|
4 Participants
|
7 Participants
|
71 Participants
|
93 Participants
|
30 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
QTcF Values Post Baseline by Daily Dose
QTcF Post-Baseline 481-500 msec
|
0 Participants
|
1 Participants
|
23 Participants
|
24 Participants
|
11 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
QTcF Values Post Baseline by Daily Dose
QTcF Post-Baseline >=501 msec
|
0 Participants
|
1 Participants
|
22 Participants
|
29 Participants
|
19 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening to End of Treatment, up to approximately 42 monthsPopulation: Safety population by daily dose
QTcF value change from baseline by daily dose (corrected using Fridericia's method, QTcF). To evaluate the effects of rociletinib on the QT (interval from Q wave to T wave)/QTc (interval corrected for heart rate) interval, all patients underwent serial ECG monitoring at Baseline, on Cycle 1 Day 1, Cycle 1 Day 15, on Day 1 of all subsequent cycles, at the EOT Visit, and as clinically indicated. Worst post-baseline QTcF value was used to categorize each patient.
Outcome measures
| Measure |
Rociletinib <900 mg BID FB Capsules
n=38 Participants
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=19 Participants
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=209 Participants
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=245 Participants
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=95 Participants
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=6 Participants
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
Rociletinib 100 mg BID FB Capsules
Rociletinib free base (FB) dose 100 mg twice a day (BID).
|
Rociletinib 300 mg BID FB Capsules
Rociletinib free base (FB) dose 300 mg twice a day (BID).
|
Rociletinib 600 mg BID FB Capsules
Rociletinib free base (FB) dose 600 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 400 mg TID FB Capsules
Rociletinib free base (FB) dose 400 mg three times a day (TID).
|
Rociletinib 500 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
QTcF Value Change From Baseline
QTcF Change from Baseline >60 msec
|
0 Participants
|
0 Participants
|
58 Participants
|
89 Participants
|
44 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
QTcF Value Change From Baseline
QTcF Change from Baseline <=30 msec
|
29 Participants
|
11 Participants
|
47 Participants
|
55 Participants
|
12 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
QTcF Value Change From Baseline
QTcF Change from Baseline 30-60 msec
|
9 Participants
|
8 Participants
|
104 Participants
|
101 Participants
|
39 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 to End of Treatment / End of Follow-upPopulation: Tumor scans were collected for independent evaluation, however ORR, DOR and PFS analyses were not performed by the central reader since the sponsor deemed not necessary following early study termination. Therefore, all IRR outcome measures were not collected and can not be reported.
Objective response rate (ORR), duration of response (DOR) and progression-free survival (PFS) per RECIST Version 1.1 as determined by independent radiology review (IRR)
Outcome measures
Outcome data not reported
Adverse Events
Rociletinib <900 mg BID FB Capsules
Serious events: 14 serious events
Other events: 37 other events
Deaths: 4 deaths
Rociletinib 900 mg BID FB Capsules
Serious events: 8 serious events
Other events: 19 other events
Deaths: 4 deaths
Rociletinib 500 mg BID HBr Tablets
Serious events: 106 serious events
Other events: 208 other events
Deaths: 31 deaths
Rociletinib 625 mg BID HBr Tablets
Serious events: 138 serious events
Other events: 244 other events
Deaths: 40 deaths
Rociletinib 750 mg BID HBr Tablets
Serious events: 54 serious events
Other events: 95 other events
Deaths: 19 deaths
Rociletinib 1000 mg BID HBr Tablets
Serious events: 5 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Rociletinib <900 mg BID FB Capsules
n=38 participants at risk
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=19 participants at risk
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=209 participants at risk
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=245 participants at risk
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=95 participants at risk
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=6 participants at risk
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.9%
4/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Pericarditis
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Eye disorders
Cataract
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.6%
4/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.2%
3/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
7/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.0%
5/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
6/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.6%
4/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
7/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
7/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Asthenia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Fatigue
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
General physical health deterioration
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Oedema peripheral
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Pain
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Pyrexia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.9%
4/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Sudden death
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Device related infection
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Endocarditis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Influenza
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Liver abscess
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Lung infection
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Pneumonia
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
7/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.1%
10/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.4%
7/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.3%
2/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Sepsis
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.9%
4/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Septic shock
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Serratia bacteraemia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.4%
3/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
General physical condition abnormal
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Lipase increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Transaminases increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Troponin increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
7/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.9%
4/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.0%
21/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.8%
19/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.4%
7/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.3%
2/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.6%
4/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
21.1%
8/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
26.3%
5/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.0%
25/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.1%
37/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
22.1%
21/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural infusion
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Basilar artery thrombosis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.4%
3/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Coma
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Headache
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.2%
3/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Seizure
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.2%
3/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Spinal cord oedema
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Syncope
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.8%
8/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.1%
10/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.0%
5/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.6%
4/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.4%
3/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.0%
5/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Vascular disorders
Hypotension
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Vascular disorders
Subgaleal haematoma
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
Other adverse events
| Measure |
Rociletinib <900 mg BID FB Capsules
n=38 participants at risk
Rociletinib free base (FB) dose \<900 mg twice a day (BID).
|
Rociletinib 900 mg BID FB Capsules
n=19 participants at risk
Rociletinib free base (FB) dose 900 mg twice a day (BID).
|
Rociletinib 500 mg BID HBr Tablets
n=209 participants at risk
Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).
|
Rociletinib 625 mg BID HBr Tablets
n=245 participants at risk
Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).
|
Rociletinib 750 mg BID HBr Tablets
n=95 participants at risk
Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).
|
Rociletinib 1000 mg BID HBr Tablets
n=6 participants at risk
Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.4%
3/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Blood and lymphatic system disorders
Anaemia
|
13.2%
5/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
22.5%
47/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
30.2%
74/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
20.0%
19/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.8%
8/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
8/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.3%
6/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.3%
9/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.7%
9/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.8%
10/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.5%
11/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.4%
7/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.0%
21/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.8%
19/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
17.9%
17/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Sinus tachycardia
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.8%
10/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Ear and labyrinth disorders
Dysacusis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Eye disorders
Cataract
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.7%
16/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
11.8%
29/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
17.9%
17/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.3%
2/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Eye disorders
Diplopia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Eye disorders
Dry eye
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.9%
4/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.7%
9/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Eye disorders
Vision blurred
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.2%
13/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.3%
18/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
13.7%
13/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Eye disorders
Visual acuity reduced
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.9%
4/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Eye disorders
Visual impairment
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.0%
5/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.2%
3/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.4%
3/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.8%
8/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
8/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.2%
3/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Abdominal pain
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
21.1%
4/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.0%
25/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.9%
39/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
17.9%
17/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.2%
15/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.3%
18/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
11.6%
11/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.3%
2/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Constipation
|
23.7%
9/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
20.1%
42/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
38.4%
94/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
27.4%
26/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.3%
2/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Diarrhoea
|
21.1%
8/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
57.9%
11/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
57.9%
121/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
59.6%
146/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
56.8%
54/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
50.0%
3/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.4%
26/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
9.0%
22/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.8%
16/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
7/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
6/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
5/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.4%
3/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
22/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.6%
26/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.6%
12/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Nausea
|
36.8%
14/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
57.9%
11/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
45.5%
95/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
56.3%
138/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
53.7%
51/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
50.0%
3/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.0%
5/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.4%
3/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Toothache
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Vomiting
|
23.7%
9/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
31.6%
6/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
31.1%
65/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.5%
82/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.7%
32/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.3%
2/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Asthenia
|
15.8%
6/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
13.4%
28/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
13.9%
34/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
17.9%
17/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Catheter site pain
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Chills
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
6/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.7%
9/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Face oedema
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Fatigue
|
23.7%
9/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
42.1%
8/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
52.2%
109/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
50.6%
124/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
49.5%
47/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
50.0%
3/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Feeling abnormal
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Feeling cold
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Gait disturbance
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.8%
8/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.1%
10/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Influenza like illness
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Malaise
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Non-cardiac chest pain
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.3%
9/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.3%
18/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.2%
4/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Oedema peripheral
|
10.5%
4/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
19.1%
40/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.7%
31/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
14.7%
14/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Pain
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
7/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
8/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.3%
6/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Pyrexia
|
10.5%
4/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
9.1%
19/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
11.0%
27/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.4%
7/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
General disorders
Temperature intolerance
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
6/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
6/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
5/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Immune system disorders
Seasonal allergy
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.2%
3/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Candida infection
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.0%
5/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.6%
4/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Cystitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.4%
3/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Eye infection
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
6/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.7%
9/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Pneumonia
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.7%
12/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.1%
15/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
11.6%
11/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.3%
2/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
6/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.7%
9/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
6/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
11.0%
23/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.5%
16/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
14.7%
14/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.9%
27/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.2%
25/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
18.9%
18/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.7%
14/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.7%
14/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.2%
4/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.3%
9/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
8/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.2%
4/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Alanine aminotransferase increased
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
9.1%
19/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.6%
26/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
8.4%
8/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Amylase increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Aspartate aminotransferase increased
|
10.5%
4/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
21.1%
4/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.0%
21/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.6%
26/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
10/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Blood alkaline phosphatase increased
|
10.5%
4/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.2%
13/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.5%
16/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.4%
7/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
21.1%
4/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.7%
16/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.1%
15/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
13.7%
13/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.2%
13/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
8.2%
20/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.4%
7/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Blood glucose increased
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.9%
4/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.7%
9/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.4%
7/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.3%
2/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Blood urine present
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
29.2%
61/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
31.4%
77/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
34.7%
33/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
50.0%
3/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.9%
12/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Insulin C-peptide increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.5%
11/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
5/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Lipase increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.4%
3/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.7%
12/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
8/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Neutrophil count increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Platelet count decreased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
9.6%
20/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.9%
17/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.2%
3/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
QRS axis abnormal
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Transaminases increased
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.6%
4/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
Weight decreased
|
10.5%
4/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
21.1%
4/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
28.2%
59/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
25.7%
63/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
41.1%
39/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.3%
2/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Investigations
White blood cell count decreased
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
9.1%
19/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
8.2%
20/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.7%
9/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
52.6%
10/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
38.3%
80/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
37.6%
92/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
45.3%
43/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
66.7%
4/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Dehydration
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
21.1%
4/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.0%
21/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.2%
30/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.6%
12/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
6/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.7%
9/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
11.6%
11/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.5%
4/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
52.6%
10/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
54.1%
113/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
60.0%
147/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
58.9%
56/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
50.0%
3/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
7/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
6/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
8.6%
18/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
9.0%
22/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.2%
3/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
6/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.5%
11/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
8/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.3%
6/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.9%
27/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
18.0%
44/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
14.7%
14/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.0%
25/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.2%
30/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
10/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.3%
2/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.0%
25/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
9.8%
24/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
8.4%
8/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.2%
5/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
11.0%
23/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.7%
31/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
13.7%
13/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.8%
6/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.4%
26/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
17.6%
43/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
15/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.9%
4/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.6%
4/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.6%
4/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.2%
3/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.2%
3/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.5%
4/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
31.6%
6/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
27.3%
57/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
29.0%
71/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
28.4%
27/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.3%
2/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.3%
9/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.9%
12/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
5/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.7%
12/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
8.6%
21/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
13.7%
13/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
21.1%
8/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
9.6%
20/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
9.0%
22/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
10/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.2%
5/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
21.1%
4/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
11.0%
23/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.5%
16/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
10/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.7%
14/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
9.4%
23/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
5/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
28.9%
11/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
26.3%
5/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
13.4%
28/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.5%
38/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
27.4%
26/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Ageusia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Amnesia
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.9%
4/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Dizziness
|
10.5%
4/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
21.1%
4/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.0%
25/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
41/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
14.7%
14/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Dysgeusia
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
8.1%
17/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.5%
16/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
5/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Headache
|
15.8%
6/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
26.3%
5/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
27.3%
57/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
23.3%
57/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
21.1%
20/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.4%
3/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Hypoaesthesia
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
6/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Neuropathy peripheral
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.7%
9/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.2%
4/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Paraesthesia
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.8%
10/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.9%
17/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.2%
4/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Seizure
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
6/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
5/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Tremor
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
7/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
7/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.2%
4/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.41%
1/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
9.1%
19/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
8.2%
20/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
8.4%
8/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.8%
8/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
13/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.2%
3/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Psychiatric disorders
Depression
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.8%
8/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.9%
12/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.2%
4/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Psychiatric disorders
Insomnia
|
10.5%
4/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
9.1%
19/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.7%
31/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
8.4%
8/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.82%
2/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Pollakiuria
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.8%
8/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.9%
12/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.7%
9/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
29.7%
62/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
24.1%
59/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
15/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.9%
4/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
6/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Dypnoea
|
26.3%
10/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
24.4%
51/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
26.5%
65/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
21.1%
20/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
33.3%
2/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.7%
12/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.7%
9/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.4%
7/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.3%
7/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.9%
12/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.4%
3/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.9%
12/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
6/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
7/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
6/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
7/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.8%
8/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
7/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
6/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
13/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
5/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.6%
4/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.9%
7/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.2%
3/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
6/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.96%
2/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.1%
1/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.48%
1/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.9%
4/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.2%
3/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.2%
13/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.7%
9/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
11.6%
11/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
15.8%
3/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
6.7%
14/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.3%
18/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
5/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.6%
1/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.4%
5/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.9%
12/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.2%
4/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
3/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
10.5%
2/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
8.1%
17/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
13/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
12.6%
12/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
16.7%
1/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Vascular disorders
Flushing
|
5.3%
2/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Vascular disorders
Hypertension
|
13.2%
5/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.7%
16/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
4.5%
11/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
7.4%
7/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
|
Vascular disorders
Hypotension
|
0.00%
0/38 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
5.3%
1/19 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
1.9%
4/209 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
3.7%
9/245 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
2.1%
2/95 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
0.00%
0/6 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All parties agree to submit all manuscripts or abstracts to all other parties 30 days prior to submission. This will enable all parties to protect proprietary information and to provide comments based on information that may not yet be available to other parties. The sponsor may request a delay in publication if there are important intellectual property concerns relating to publication, but does not have the right to suppress publication of the study results indefinitely.
- Publication restrictions are in place
Restriction type: OTHER