Trial Outcomes & Findings for Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer (NCT NCT02147990)
NCT ID: NCT02147990
Last Updated: 2020-08-12
Results Overview
ORR is defined as the percentage of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression. For patients who continued treatment post-progression, the first date of progression was used for the analysis. 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
PHASE2
Target enrollment
318 participants
Primary outcome timeframe
Cycle 1 Day 1 to End of Treatment, up to approximately 57 months.
Results posted on
2020-08-12
Participant Flow
318 patients were enrolled at 67 study sites in North America, Europe, Asia and Australia. One patient was not included in the Safety Population due to failure of the study site to provide any dosing data in electronic data capture (EDC) before the site was closed.
Participant milestones
| Measure |
Rociletinib 625 mg BID T790M+
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Overall Study
STARTED
|
154
|
100
|
63
|
|
Overall Study
COMPLETED
|
154
|
100
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
Total
n=317 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 10.67 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 9.93 • n=7 Participants
|
64.1 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 10.34 • n=4 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
215 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
131 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
279 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
59 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
T790M Status
T790M Negative
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
T790M Status
T790M Positive
|
153 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
T790M Status
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 to End of Treatment, up to approximately 57 months.Population: Investigator Tumor Evaluable Population - defined as all patients who received at least 1 dose of rociletinib, have at least 1 measureable tumor lesion at baseline, and have at least 1 post-baseline tumor assessment as determined by the investigator.
ORR is defined as the percentage of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression. For patients who continued treatment post-progression, the first date of progression was used for the analysis. 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 625 mg BID T790M+
n=153 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=97 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=61 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Objective Response Rate (ORR) According to RECIST Version 1.1 as Determined by Investigator Assessment
|
34.6 percentage of participants
Interval 27.1 to 42.7
|
34.0 percentage of participants
Interval 24.7 to 44.3
|
18.0 percentage of participants
Interval 9.4 to 30.0
|
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 54 monthsPopulation: Centrally-confirmed T790M-positive subset of the Investigator Tumor Evaluable Population - defined as all patients who received at least 1 dose of rociletinib, have at least 1 measureable tumor lesion at baseline, and have at least 1 post-baseline tumor assessment as determined by the investigator.
DOR 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 625 mg BID T790M+
n=53 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=33 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=86 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Duration of Response (DOR) in T790M Positive Patients According to RECIST Version 1.1 as Determined by Investigator Assessment
|
7.4 months
Interval 5.5 to 9.4
|
9.1 months
Interval 5.6 to 13.0
|
7.6 months
Interval 7.3 to 9.4
|
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 57 monthsPopulation: Investigator Tumor Evaluable Population - defined as all patients who received at least 1 dose of rociletinib, have at least 1 measureable tumor lesion at baseline, and have at least 1 post-baseline tumor assessment as determined by the investigator.
DCR is defined as the percentage of patients who have achieved CR, PR, and SD lasting at least 12 weeks. 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. Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=153 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=97 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=61 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Disease Control Rate (DCR) by RECIST v1.1 as Determined by Investigator Assessment
|
67.3 percentage of patients
Interval 59.3 to 74.7
|
76.3 percentage of patients
Interval 66.6 to 84.3
|
59.0 percentage of patients
Interval 45.7 to 71.4
|
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 57 monthsPopulation: Centrally-confirmed T790M-positive subset of the Intent-to-treat (ITT) population defined as all patients who received at least 1 dose of rociletinib.
PFS was calculated as 1+ the number of days from the first dose of study drug to documented radiographic progression or death due to any cause, whichever occurs first. Patients without a documented event of radiographic 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 were performed. For patients who continued treatment post-progression, the first date of progression was used for the analysis of PFS. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=254 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Progression-free Survival (PFS) in T790M Positive Patients by RECIST v1.1 as Determined by Investigator Assessment
|
5.5 months
Interval 4.0 to 6.7
|
5.9 months
Interval 5.3 to 8.3
|
5.5 months
Interval 5.3 to 7.2
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 to date of death, assessed up to 57 monthsPopulation: Centrally-confirmed T790M-positive subset of the Intent-to-treat (ITT) population defined as all patients who received at least 1 dose of rociletinib.
OS 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 will be censored on the date the patient was last known to be alive.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=254 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Overall Survival (OS) Determined by Investigator Assessment
|
18.8 months
Interval 15.2 to
There are an insufficient number of participants with events.
|
29.8 months
Interval 26.2 to
There are an insufficient number of participants with events.
|
23.7 months
Interval 17.7 to 40.6
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Quality of Life Scale
Baseline (Day 0)
|
62.18 units on a scale
Standard Deviation 22.245
|
59.76 units on a scale
Standard Deviation 22.495
|
54.63 units on a scale
Standard Deviation 24.629
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Quality of Life Scale
Cycle 5 (approximately month 5)
|
-2.48 units on a scale
Standard Deviation 22.470
|
-0.56 units on a scale
Standard Deviation 23.763
|
5.56 units on a scale
Standard Deviation 28.842
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Quality of Life Scale
Cycle 10 (approximately month 10)
|
-2.21 units on a scale
Standard Deviation 22.294
|
-3.81 units on a scale
Standard Deviation 21.422
|
3.57 units on a scale
Standard Deviation 23.956
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Quality of Life Scale
End of Treatment
|
-4.82 units on a scale
Standard Deviation 23.381
|
-9.65 units on a scale
Standard Deviation 18.481
|
-10.42 units on a scale
Standard Deviation 35.158
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in Dermatology Life Quality Index (DLQI)
Baseline (Day 0)
|
2.10 units on a scale
Standard Deviation 3.408
|
2.42 units on a scale
Standard Deviation 4.706
|
2.74 units on a scale
Standard Deviation 4.763
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in Dermatology Life Quality Index (DLQI)
Cycle 5 (approximately month 5)
|
-0.82 units on a scale
Standard Deviation 3.240
|
-1.29 units on a scale
Standard Deviation 3.499
|
-1.63 units on a scale
Standard Deviation 3.731
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in Dermatology Life Quality Index (DLQI)
Cycle 10 (approximately month 10)
|
-1.02 units on a scale
Standard Deviation 2.810
|
-1.64 units on a scale
Standard Deviation 3.531
|
-0.79 units on a scale
Standard Deviation 2.751
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in Dermatology Life Quality Index (DLQI)
End of Treatment
|
-0.77 units on a scale
Standard Deviation 3.191
|
-0.22 units on a scale
Standard Deviation 2.157
|
-1.14 units on a scale
Standard Deviation 4.204
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Alopecia Scale
Cycle 10 (approximately month 10)
|
-2.00 units on a scale
Standard Deviation 21.728
|
-6.67 units on a scale
Standard Deviation 25.309
|
-2.56 units on a scale
Standard Deviation 21.350
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Alopecia Scale
Baseline (Day 0)
|
9.96 units on a scale
Standard Deviation 21.264
|
9.43 units on a scale
Standard Deviation 20.779
|
19.05 units on a scale
Standard Deviation 29.154
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Alopecia Scale
Cycle 5 (approximately month 5)
|
-4.62 units on a scale
Standard Deviation 27.499
|
-2.69 units on a scale
Standard Deviation 27.855
|
-10.10 units on a scale
Standard Deviation 19.516
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Alopecia Scale
End of Treatment
|
4.50 units on a scale
Standard Deviation 33.483
|
3.51 units on a scale
Standard Deviation 44.298
|
0.00 units on a scale
Standard Deviation 39.841
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Coughing Scale
Baseline (Day 0)
|
33.12 units on a scale
Standard Deviation 26.540
|
29.97 units on a scale
Standard Deviation 25.862
|
38.62 units on a scale
Standard Deviation 23.346
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Coughing Scale
Cycle 5 (approximately month 5)
|
-7.92 units on a scale
Standard Deviation 26.728
|
-9.29 units on a scale
Standard Deviation 26.619
|
-12.12 units on a scale
Standard Deviation 27.409
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Coughing Scale
Cycle 10 (approximately month 10)
|
-6.67 units on a scale
Standard Deviation 23.328
|
-17.14 units on a scale
Standard Deviation 30.648
|
2.56 units on a scale
Standard Deviation 21.350
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Coughing Scale
End of Treatment
|
-5.41 units on a scale
Standard Deviation 27.793
|
0.00 units on a scale
Standard Deviation 36.851
|
6.67 units on a scale
Standard Deviation 25.820
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dysphagia Scale
Baseline (Day 0)
|
5.19 units on a scale
Standard Deviation 15.306
|
7.41 units on a scale
Standard Deviation 17.532
|
5.82 units on a scale
Standard Deviation 17.495
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dysphagia Scale
Cycle 5 (approximately month 5)
|
1.65 units on a scale
Standard Deviation 12.803
|
-0.54 units on a scale
Standard Deviation 17.589
|
7.07 units on a scale
Standard Deviation 21.663
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dysphagia Scale
Cycle 10 (approximately month 10)
|
-3.27 units on a scale
Standard Deviation 13.752
|
-3.81 units on a scale
Standard Deviation 15.700
|
2.56 units on a scale
Standard Deviation 9.245
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dysphagia Scale
End of Treatment
|
3.60 units on a scale
Standard Deviation 17.184
|
7.41 units on a scale
Standard Deviation 31.427
|
6.67 units on a scale
Standard Deviation 28.730
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dyspnoea Scale
Baseline (Day 0)
|
21.79 units on a scale
Standard Deviation 21.554
|
22.56 units on a scale
Standard Deviation 21.441
|
30.34 units on a scale
Standard Deviation 26.415
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dyspnoea Scale
Cycle 5 (approximately month 5)
|
6.11 units on a scale
Standard Deviation 21.681
|
-1.25 units on a scale
Standard Deviation 18.777
|
-3.70 units on a scale
Standard Deviation 23.516
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dyspnoea Scale
Cycle 10 (approximately month 10)
|
2.83 units on a scale
Standard Deviation 19.606
|
1.90 units on a scale
Standard Deviation 14.879
|
6.84 units on a scale
Standard Deviation 22.923
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dyspnoea Scale
End of Treatment
|
8.41 units on a scale
Standard Deviation 22.892
|
8.77 units on a scale
Standard Deviation 18.362
|
0.00 units on a scale
Standard Deviation 28.172
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Haemoptysis Scale
Baseline (Day 0)
|
2.38 units on a scale
Standard Deviation 8.613
|
1.68 units on a scale
Standard Deviation 11.039
|
4.76 units on a scale
Standard Deviation 13.194
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Haemoptysis Scale
Cycle 5 (approximately month 5)
|
-1.98 units on a scale
Standard Deviation 7.919
|
-1.61 units on a scale
Standard Deviation 9.404
|
-5.21 units on a scale
Standard Deviation 14.930
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Haemoptysis Scale
Cycle 10 (approximately month 10)
|
-0.65 units on a scale
Standard Deviation 8.138
|
-0.95 units on a scale
Standard Deviation 5.634
|
-5.13 units on a scale
Standard Deviation 18.490
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Haemoptysis Scale
End of Treatment
|
-0.90 units on a scale
Standard Deviation 12.389
|
0.00 units on a scale
Standard Deviation 0.000
|
-2.22 units on a scale
Standard Deviation 8.607
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Arm or Shoulder Scale
Baseline (Day 0)
|
19.91 units on a scale
Standard Deviation 26.271
|
16.67 units on a scale
Standard Deviation 26.325
|
28.42 units on a scale
Standard Deviation 34.338
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Arm or Shoulder Scale
Cycle 5 (approximately month 5)
|
-5.94 units on a scale
Standard Deviation 32.110
|
-2.69 units on a scale
Standard Deviation 25.819
|
-7.29 units on a scale
Standard Deviation 35.655
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Arm or Shoulder Scale
Cycle 10 (approximately month 10)
|
-1.31 units on a scale
Standard Deviation 31.242
|
-2.86 units on a scale
Standard Deviation 27.262
|
8.33 units on a scale
Standard Deviation 28.868
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Arm or Shoulder Scale
End of Treatment
|
5.41 units on a scale
Standard Deviation 29.932
|
0.00 units on a scale
Standard Deviation 35.136
|
4.44 units on a scale
Standard Deviation 33.014
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Chest Scale
Baseline (Day 0)
|
19.91 units on a scale
Standard Deviation 25.429
|
12.79 units on a scale
Standard Deviation 22.691
|
25.40 units on a scale
Standard Deviation 32.635
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Chest Scale
Cycle 5 (approximately month 5)
|
-4.62 units on a scale
Standard Deviation 25.399
|
-5.38 units on a scale
Standard Deviation 20.194
|
-8.08 units on a scale
Standard Deviation 28.904
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Chest Scale
Cycle 10 (approximately month 10)
|
-3.27 units on a scale
Standard Deviation 24.272
|
-6.86 units on a scale
Standard Deviation 19.728
|
2.56 units on a scale
Standard Deviation 39.585
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Chest Scale
End of Treatment
|
1.80 units on a scale
Standard Deviation 34.198
|
7.02 units on a scale
Standard Deviation 13.962
|
-4.44 units on a scale
Standard Deviation 30.516
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Medicine for Pain Scale
Baseline (Day 0)
|
60.47 units on a scale
Standard Deviation 27.302
|
66.67 units on a scale
Standard Deviation 27.766
|
53.17 units on a scale
Standard Deviation 23.350
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Medicine for Pain Scale
Cycle 5 (approximately month 5)
|
6.67 units on a scale
Standard Deviation 35.450
|
8.89 units on a scale
Standard Deviation 23.458
|
-4.76 units on a scale
Standard Deviation 36.648
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Medicine for Pain Scale
Cycle 10 (approximately month 10)
|
4.76 units on a scale
Standard Deviation 12.105
|
-4.17 units on a scale
Standard Deviation 27.817
|
22.22 units on a scale
Standard Deviation 19.245
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Medicine for Pain Scale
End of Treatment
|
3.92 units on a scale
Standard Deviation 20.008
|
0.00 units on a scale
Standard Deviation 30.861
|
-5.56 units on a scale
Standard Deviation 38.968
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Other Parts Scale
Baseline (Day 0)
|
28.41 units on a scale
Standard Deviation 30.848
|
30.58 units on a scale
Standard Deviation 33.219
|
31.69 units on a scale
Standard Deviation 29.456
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Other Parts Scale
Cycle 5 (approximately month 5)
|
2.46 units on a scale
Standard Deviation 34.464
|
-1.13 units on a scale
Standard Deviation 29.664
|
-7.78 units on a scale
Standard Deviation 33.543
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Other Parts Scale
Cycle 10 (approximately month 10)
|
-3.47 units on a scale
Standard Deviation 28.550
|
-6.67 units on a scale
Standard Deviation 31.102
|
-2.78 units on a scale
Standard Deviation 22.285
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Other Parts Scale
End of Treatment
|
20.59 units on a scale
Standard Deviation 31.798
|
0.00 units on a scale
Standard Deviation 26.352
|
6.67 units on a scale
Standard Deviation 44.006
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Peripheral Neuropathy Scale
Baseline (Day 0)
|
11.90 units on a scale
Standard Deviation 22.117
|
6.40 units on a scale
Standard Deviation 17.611
|
17.20 units on a scale
Standard Deviation 29.409
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Peripheral Neuropathy Scale
Cycle 5 (approximately month 5)
|
0.00 units on a scale
Standard Deviation 25.386
|
3.76 units on a scale
Standard Deviation 23.458
|
4.17 units on a scale
Standard Deviation 31.395
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Peripheral Neuropathy Scale
Cycle 10 (approximately month 10)
|
4.58 units on a scale
Standard Deviation 25.837
|
2.86 units on a scale
Standard Deviation 18.737
|
0.00 units on a scale
Standard Deviation 20.101
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Peripheral Neuropathy Scale
End of Treatment
|
2.70 units on a scale
Standard Deviation 21.341
|
7.02 units on a scale
Standard Deviation 26.244
|
2.22 units on a scale
Standard Deviation 15.258
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Months 5, 10 and EOTPopulation: Safety population - defined as all patients who received at least 1 dose of rociletinib.
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Outcome measures
| Measure |
Rociletinib 625 mg BID T790M+
n=154 Participants
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 Participants
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 Participants
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Sore Mouth Scale
Baseline (Day 0)
|
5.19 units on a scale
Standard Deviation 13.273
|
7.41 units on a scale
Standard Deviation 17.532
|
10.58 units on a scale
Standard Deviation 21.440
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Sore Mouth Scale
Cycle 5 (approximately month 5)
|
1.98 units on a scale
Standard Deviation 18.149
|
-2.19 units on a scale
Standard Deviation 21.832
|
-2.02 units on a scale
Standard Deviation 27.562
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Sore Mouth Scale
Cycle 10 (approximately month 10)
|
0.65 units on a scale
Standard Deviation 19.425
|
-1.90 units on a scale
Standard Deviation 24.176
|
2.56 units on a scale
Standard Deviation 21.350
|
|
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Sore Mouth Scale
End of Treatment
|
4.50 units on a scale
Standard Deviation 21.026
|
12.28 units on a scale
Standard Deviation 29.836
|
2.22 units on a scale
Standard Deviation 36.659
|
SECONDARY outcome
Timeframe: Every 4 weeks for approximately 6 months (Day 1 of Cycles 2 to 7 inclusive)Population: Population PK (PPK) and exposure-response (ER) analysis were listed as a secondary objective. These analyses were conducted based on pooled data from multiple rociletinib trials (including TIGER2), thus no PPK or ER report was generated specifically for this study.
Sparse blood sampling for POPPK and ER analyses in all patients treated with rociletinib.
Outcome measures
Outcome data not reported
Adverse Events
Rociletinib 625 mg BID T790M+
Serious events: 77 serious events
Other events: 153 other events
Deaths: 27 deaths
Rociletinib 500 mg BID T790M+
Serious events: 48 serious events
Other events: 100 other events
Deaths: 7 deaths
Rociletinib 500 mg BID T790M-
Serious events: 34 serious events
Other events: 63 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Rociletinib 625 mg BID T790M+
n=154 participants at risk
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 participants at risk
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 participants at risk
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
General disorders
Euthanasia
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Fatigue
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Malaise
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Oedema peripheral
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Peripheral swelling
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Pyrexia
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.0%
3/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Sudden death
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Non-cardiac chest pain
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Oedema
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Melaena
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
6/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Pancreatitis
|
3.2%
5/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Death
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
4/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.0%
3/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.8%
3/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Chest pain
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
3/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Cardiac disorders
Bradycardia
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Cardiac disorders
Cardiac arrest
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Cardiac disorders
Pericarditis
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Eye disorders
Cataract
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.3%
4/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Eye disorders
Diplopia
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
3/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
3/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.0%
4/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Hepatobiliary disorders
Hepatitis
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Biliary tract infection
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Cellulitis
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Clostridium difficile infection
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Cystitis
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Herpes zoster
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Influenza
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Listeria sepsis
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Lung infection
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Pneumonia
|
1.9%
3/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
5.0%
5/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Sepsis
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.0%
3/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Investigations
Blood creatinine increased
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Investigations
Electrocardiogram QT prolonged
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Investigations
Haemoglobin decreased
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Investigations
Transaminases increased
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
4/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.5%
10/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.0%
6/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
3/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
14.9%
23/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.0%
4/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
11.1%
7/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Epilepsy
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Headache
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Partial seizures
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Seizure
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Syncope
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Psychiatric disorders
Confusional state
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Renal and urinary disorders
Bladder perforation
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.0%
4/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.8%
3/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Vascular disorders
Deep vein thrombosis
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Vascular disorders
Embolism
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Vascular disorders
Shock haemorrhagic
|
0.65%
1/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
Other adverse events
| Measure |
Rociletinib 625 mg BID T790M+
n=154 participants at risk
Rociletinib 625 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M+
n=100 participants at risk
Rociletinib 500 mg BID in patients with T790M-positive tumor status
|
Rociletinib 500 mg BID T790M-
n=63 participants at risk
Rociletinib 500 mg BID in patients with T790M-negative tumor status
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
11.7%
18/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
13.0%
13/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.4%
13/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.0%
4/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
11.1%
7/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.8%
32/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
13.0%
13/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
15.9%
10/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
3/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
5.0%
5/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Blood and lymphatic system disorders
Thromobcytopenia
|
7.1%
11/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Eye disorders
Cataract
|
18.2%
28/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
18.0%
18/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
11.1%
7/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Eye disorders
Vision blurred
|
4.5%
7/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
8.0%
8/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.6%
24/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
15.0%
15/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
9.5%
6/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.7%
18/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
9.0%
9/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Constipation
|
24.7%
38/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
35.0%
35/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
33.3%
21/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
59.1%
91/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
59.0%
59/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
47.6%
30/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.4%
16/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
8.0%
8/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.9%
5/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.9%
5/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Nausea
|
55.8%
86/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
58.0%
58/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
49.2%
31/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Stomatitis
|
5.8%
9/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
5.0%
5/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Vomiting
|
40.3%
62/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
35.0%
35/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
33.3%
21/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Asthenia
|
12.3%
19/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.0%
6/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
9.5%
6/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Chest pain
|
7.1%
11/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
13.0%
13/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.8%
3/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Fatigue
|
37.0%
57/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
48.0%
48/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
46.0%
29/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Influenza like illness
|
5.2%
8/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
5.0%
5/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Malaise
|
2.6%
4/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.3%
4/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Mucosal inflammation
|
3.9%
6/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.0%
7/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.8%
3/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Non-cardiac chest pain
|
5.2%
8/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.0%
1/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Oedema peripheral
|
10.4%
16/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.0%
6/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
12.7%
8/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
General disorders
Pyrexia
|
13.6%
21/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
11.0%
11/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.9%
5/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Paronychia
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
5.0%
5/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Pneumonia
|
4.5%
7/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
5.0%
5/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.9%
5/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.4%
13/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
8.0%
8/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.3%
4/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
22/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
15.0%
15/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
9.5%
6/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Investigations
Alanine aminotransferase increased
|
13.6%
21/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
9.0%
9/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
9.5%
6/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Investigations
Aspartate aminotransferase increased
|
11.7%
18/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
5.0%
5/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.9%
5/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.5%
10/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.0%
6/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.3%
4/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Investigations
Blood bilirubin increased
|
9.7%
15/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.0%
3/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Investigations
Blood creatinine increased
|
7.8%
12/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.0%
7/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.9%
5/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Investigations
Electrocardiogram QT prolonged
|
40.3%
62/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
29.0%
29/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
30.2%
19/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Investigations
Platelet count decreased
|
3.9%
6/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.3%
4/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Investigations
Weight decreased
|
27.9%
43/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
28.0%
28/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
23.8%
15/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.3%
62/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
42.0%
42/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
39.7%
25/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.4%
16/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
5.0%
5/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
63.0%
97/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
64.0%
64/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
52.4%
33/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.2%
8/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.0%
3/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.8%
3/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.7%
18/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
9.0%
9/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
12.7%
8/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.8%
12/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.0%
7/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.8%
3/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.2%
8/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
8.0%
8/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.8%
3/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
22/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
18.0%
18/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.9%
5/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.4%
16/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
19.0%
19/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
14.3%
9/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
22.7%
35/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
23.0%
23/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
15.9%
10/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
11/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.0%
7/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.3%
4/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.4%
13/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.0%
7/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.3%
4/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.7%
15/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.0%
4/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
4/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
5.0%
5/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
8/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.0%
7/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.8%
3/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
17.5%
27/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.0%
7/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
14.3%
9/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Dizziness
|
13.6%
21/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
18.0%
18/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
11.1%
7/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Dysgeusia
|
6.5%
10/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
9.0%
9/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
7.9%
5/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Headache
|
29.2%
45/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
19.0%
19/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
22.2%
14/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Nervous system disorders
Lethargy
|
1.9%
3/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
2.0%
2/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.3%
4/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Psychiatric disorders
Anxiety
|
4.5%
7/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.0%
4/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.3%
4/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Psychiatric disorders
Confusional state
|
5.2%
8/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.0%
3/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Psychiatric disorders
Depression
|
3.2%
5/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.0%
6/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.8%
3/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Psychiatric disorders
Insomnia
|
8.4%
13/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
10.0%
10/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
9.5%
6/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.7%
35/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
25.0%
25/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
28.6%
18/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.0%
6/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
28/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
24.0%
24/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
23.8%
15/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.2%
5/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.0%
6/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
1.6%
1/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.6%
4/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.3%
4/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.5%
7/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.0%
6/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
9.5%
6/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.2%
8/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.0%
4/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.3%
4/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.3%
2/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
5.0%
5/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
11/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
8.0%
8/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.2%
8/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
5.0%
5/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
11.1%
7/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.8%
9/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
9.0%
9/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
3.2%
2/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Vascular disorders
Hypertension
|
5.8%
9/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.0%
4/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
4.8%
3/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Vascular disorders
Hypotension
|
3.2%
5/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
5.0%
5/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.9%
6/154 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
6.0%
6/100 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
0.00%
0/63 • Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
|
Additional Information
Medical Information Department
Clovis Oncology, Inc.
Phone: +1 415 409 7220
Email: [email protected]
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