Trial Outcomes & Findings for Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer (NCT NCT01822496)
NCT ID: NCT01822496
Last Updated: 2019-08-05
Results Overview
Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression-free survival time is measured from the date of randomization to the date of first progression, death, or last known follow-up (censored). No statistical testing was done due to early study termination.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
From randomization to study termination. Maximum follow-up was 39.0 months
Results posted on
2019-08-05
Participant Flow
Participant milestones
| Measure |
EGFR: Erlotinib
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
EGFR: No Erlotinib
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
ALK: Crizotinib
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
ALK: No Crizotinib
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
23
|
9
|
11
|
|
Overall Study
Eligible
|
14
|
21
|
9
|
7
|
|
Overall Study
Eligible With Disease Assessment
|
10
|
15
|
6
|
4
|
|
Overall Study
Eligible and Started Study Treatment
|
14
|
20
|
9
|
7
|
|
Overall Study
COMPLETED
|
14
|
21
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
4
|
Reasons for withdrawal
| Measure |
EGFR: Erlotinib
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
EGFR: No Erlotinib
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
ALK: Crizotinib
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
ALK: No Crizotinib
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
EGFR: Erlotinib
n=14 Participants
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
EGFR: No Erlotinib
n=21 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
ALK: Crizotinib
n=9 Participants
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
ALK: No Crizotinib
n=7 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age (years) · ≤ 49
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Age, Customized
Age (years) · 50 - 59
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Age, Customized
Age (years) · 60 -69
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Age, Customized
Age (years) · ≥ 70
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
39 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 monthsPopulation: Eligible patients
Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression-free survival time is measured from the date of randomization to the date of first progression, death, or last known follow-up (censored). No statistical testing was done due to early study termination.
Outcome measures
| Measure |
EGFR: Erlotinib
n=14 Participants
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
EGFR: No Erlotinib
n=21 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
ALK: Crizotinib
n=9 Participants
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
ALK: No Crizotinib
n=7 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
|---|---|---|---|---|
|
Progression-free Survival
|
21.1 months
Interval 8.5 to
Not reached
|
9.2 months
Interval 8.7 to
Not reached
|
14.7 months
Interval 6.4 to 19.5
|
NA months
Not reached
|
SECONDARY outcome
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 monthsPopulation: Eligible patients with disease assessment
Per the RECIST guideline v1.1 complete response is defined as the 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 is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. No statistical testing was done due to early study termination.
Outcome measures
| Measure |
EGFR: Erlotinib
n=10 Participants
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
EGFR: No Erlotinib
n=15 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
ALK: Crizotinib
n=6 Participants
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
ALK: No Crizotinib
n=4 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
|---|---|---|---|---|
|
Percentage of Patients With Complete or Partial Response
|
50.0 percentage of participants
Interval 19.0 to 81.0
|
26.7 percentage of participants
Interval 4.3 to 49.1
|
66.7 percentage of participants
Interval 29.0 to 100.0
|
75.0 percentage of participants
Interval 32.6 to 100.0
|
SECONDARY outcome
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 monthsPopulation: Eligible patients who started study treatment
Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
EGFR: Erlotinib
n=14 Participants
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
EGFR: No Erlotinib
n=20 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
ALK: Crizotinib
n=9 Participants
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
ALK: No Crizotinib
n=7 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
|---|---|---|---|---|
|
Number of Patients With Grade 3-5 Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 monthsPopulation: Eligible patients
Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Outcome measures
| Measure |
EGFR: Erlotinib
n=14 Participants
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
EGFR: No Erlotinib
n=21 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
ALK: Crizotinib
n=9 Participants
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
ALK: No Crizotinib
n=7 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
|---|---|---|---|---|
|
Overall Survival
|
NA Months
Not reached
|
35.9 Months
Interval 35.9 to
Not reached
|
NA Months
Not reached
|
NA Months
Not reached
|
SECONDARY outcome
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 monthsPopulation: Eligible patients
Progression is defined using the RECIST guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new regional lesions. Local progression is defined as progression within the planning target volume (PTV). Regional progression is defined as progression outside of the PTV but within the same lobe of the lung as the primary tumor or in regional lymph nodes as defined by the American Joint Committee on Cancer (AJCC) 7th edition nodal stations. Local-regional progression-free survival time is measured from the date of randomization to the date of first local-regional progression, death, or last known follow-up (censored). Local-regional progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination.
Outcome measures
| Measure |
EGFR: Erlotinib
n=14 Participants
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
EGFR: No Erlotinib
n=21 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
ALK: Crizotinib
n=9 Participants
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
ALK: No Crizotinib
n=7 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
|---|---|---|---|---|
|
Local-regional Progression-free Survival
|
25.7 Months
Interval 8.5 to
Not reached
|
NA Months
Not reached
|
14.7 Months
Interval 6.4 to 19.5
|
NA Months
Not reached
|
SECONDARY outcome
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 monthsPopulation: Eligible patients
Distant progression is defined as the first occurrence of distant metastasis. Distant progression-free survival time is measured from the date of randomization to the date of first distant progression, death, or last known follow-up (censored). Distant progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination.
Outcome measures
| Measure |
EGFR: Erlotinib
n=14 Participants
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
EGFR: No Erlotinib
n=21 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
ALK: Crizotinib
n=9 Participants
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
ALK: No Crizotinib
n=7 Participants
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
|---|---|---|---|---|
|
Distant Progression-free Survival
|
NA Months
Not reached
|
35.9 Months
Interval 8.9 to 35.9
|
NA Months
Not reached
|
20.1 Months
Interval 7.8 to
Not reached
|
SECONDARY outcome
Timeframe: BaselinePopulation: The data required for this analysis was not obtained and will not be obtained.
Outcome measures
Outcome data not reported
Adverse Events
EGFR: Erlotinib
Serious events: 1 serious events
Other events: 14 other events
Deaths: 1 deaths
EGFR: No Erlotinib
Serious events: 7 serious events
Other events: 20 other events
Deaths: 3 deaths
ALK: Crizotinib
Serious events: 4 serious events
Other events: 8 other events
Deaths: 2 deaths
ALK: No Crizotinib
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
EGFR: Erlotinib
n=14 participants at risk
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
EGFR: No Erlotinib
n=20 participants at risk
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
ALK: Crizotinib
n=9 participants at risk
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
ALK: No Crizotinib
n=7 participants at risk
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Esophageal fistula
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fever
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Lung infection
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight loss
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
EGFR: Erlotinib
n=14 participants at risk
Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
EGFR: No Erlotinib
n=20 participants at risk
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
ALK: Crizotinib
n=9 participants at risk
Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
|
ALK: No Crizotinib
n=7 participants at risk
Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
3/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
30.0%
6/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Anemia
|
57.1%
8/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
10/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
85.7%
6/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Palpitations
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Sinus tachycardia
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Ear and labyrinth disorders
Tinnitus
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Endocrine disorders
Endocrine disorders - Other
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Blurred vision
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Cataract
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Dry eye
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Eye disorders - Other
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Flashing lights
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Floaters
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
40.0%
8/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Bloating
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
42.9%
6/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
55.0%
11/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
71.4%
5/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
57.1%
8/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
10/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
55.6%
5/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
35.7%
5/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
5/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
57.1%
8/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
30.0%
6/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
57.1%
4/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Esophageal obstruction
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Esophageal pain
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Esophagitis
|
71.4%
10/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
60.0%
12/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.9%
3/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
3/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastroparesis
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Mucositis oral
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
71.4%
10/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
80.0%
16/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
66.7%
6/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
57.1%
4/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Oral pain
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
30.0%
6/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Chills
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Death NOS
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema face
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema limbs
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
57.1%
4/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
92.9%
13/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
70.0%
14/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
66.7%
6/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
100.0%
7/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fever
|
35.7%
5/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Flu like symptoms
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
General disorders and administration site conditions - Other
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Irritability
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Malaise
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Non-cardiac chest pain
|
28.6%
4/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
3/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.9%
3/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Immune system disorders
Allergic reaction
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Lung infection
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Mucosal infection
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Otitis media
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Papulopustular rash
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Paronychia
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Rash pustular
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Sinusitis
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Skin infection
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Upper respiratory infection
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Uterine infection
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
57.1%
8/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
30.0%
6/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
57.1%
4/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
4/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
3/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood bilirubin increased
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Creatinine increased
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
5/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
INR increased
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Investigations - Other
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphocyte count decreased
|
57.1%
8/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
10/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
57.1%
4/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count decreased
|
28.6%
4/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
35.0%
7/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.9%
3/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
35.7%
5/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
45.0%
9/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
71.4%
5/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight gain
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight loss
|
35.7%
5/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
3/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
White blood cell decreased
|
35.7%
5/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
30.0%
6/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
57.1%
4/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
6/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
45.0%
9/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.9%
3/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
28.6%
4/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.0%
4/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
30.0%
6/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
71.4%
5/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.0%
4/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.9%
3/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
4/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
3/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.0%
4/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
35.7%
5/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
3/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Concentration impairment
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
5/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.9%
3/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysgeusia
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
30.0%
6/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Nervous system disorders - Other
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Olfactory nerve disorder
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
3/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
35.7%
5/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
45.0%
9/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
57.1%
4/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Presyncope
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Tremor
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Agitation
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Anxiety
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
3/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Depression
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Insomnia
|
50.0%
7/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.0%
4/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Restlessness
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary frequency
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary urgency
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
85.7%
12/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
60.0%
12/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
85.7%
6/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
7/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
45.0%
9/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
57.1%
4/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
28.6%
4/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
3/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.9%
3/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.4%
3/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
35.0%
7/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
57.1%
4/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Body odor
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
7/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
3/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.0%
4/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
57.1%
8/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.0%
3/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
28.6%
4/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
1/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hot flashes
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.0%
4/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypotension
|
14.3%
2/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.0%
1/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.0%
2/20 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
28.6%
2/7 • From randomization to last follow-up. Maximum follow-up was 39.0 months.
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER