Trial Outcomes & Findings for Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma (NCT NCT01223027)
NCT ID: NCT01223027
Last Updated: 2015-12-07
Results Overview
Assessed according to RECIST 1.1. PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. If a patient had not progressed or died, on the date of the analysis cut-off or when he/she received any further anti-neoplastic therapy, PFS was censored on the date of last tumor assessment before the cutoff date or the anti-neoplastic therapy date. The distribution of PFS was estimated using the Kaplan-Meier method. The median PFS along with 95% confidence intervals was presented by treatment group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
564 participants
Primary outcome timeframe
Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)
Results posted on
2015-12-07
Participant Flow
Participant milestones
| Measure |
Dovitinib + Best Supportive Care (BSC)
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib + BSC
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
284
|
286
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
274
|
277
|
Reasons for withdrawal
| Measure |
Dovitinib + Best Supportive Care (BSC)
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib + BSC
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
20
|
10
|
|
Overall Study
Death
|
42
|
42
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
4
|
8
|
|
Overall Study
Progressive Disease
|
167
|
183
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Subject/guardian decicion
|
18
|
16
|
|
Overall Study
New therapy for study indication
|
17
|
8
|
|
Overall Study
Study terminated by sponsor
|
2
|
8
|
Baseline Characteristics
Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Dovitinib + Best Supportive Care (BSC)
n=284 Participants
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib + BSC
n=286 Participants
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
Total
n=570 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
187 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
97 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
213 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
233 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
465 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Weight
|
74.9 kg
STANDARD_DEVIATION 15.39 • n=5 Participants
|
75.5 kg
STANDARD_DEVIATION 15.96 • n=7 Participants
|
75.2 kg
STANDARD_DEVIATION 15.67 • n=5 Participants
|
|
Karnofsky performance score
100 -Normal no complaints; no evidence of disease
|
83 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Karnofsky performance score
90 - Able to carry on normal activity
|
93 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Karnofsky performance score
80 - Normal activity with efforts
|
73 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Karnofsky performance score
70 - Cares for self
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Memorial Sloan Kettering Cancer Center Risk Criteria (MSKCC) risk group
Favorable
|
70 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Memorial Sloan Kettering Cancer Center Risk Criteria (MSKCC) risk group
Intermediate
|
156 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
311 Participants
n=5 Participants
|
|
Memorial Sloan Kettering Cancer Center Risk Criteria (MSKCC) risk group
Poor
|
54 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Memorial Sloan Kettering Cancer Center Risk Criteria (MSKCC) risk group
Missing
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)Population: Full Analysis Set (FAS) consisted of all randomized patients.
Assessed according to RECIST 1.1. PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. If a patient had not progressed or died, on the date of the analysis cut-off or when he/she received any further anti-neoplastic therapy, PFS was censored on the date of last tumor assessment before the cutoff date or the anti-neoplastic therapy date. The distribution of PFS was estimated using the Kaplan-Meier method. The median PFS along with 95% confidence intervals was presented by treatment group.
Outcome measures
| Measure |
Dovitinib + Best Supportive Care (BSC)
n=284 Participants
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib + BSC
n=286 Participants
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Progression Free Survival (PFS) Per Independent Central Radiology Review
|
3.7 Months
Interval 3.5 to 3.9
|
3.6 Months
Interval 3.5 to 3.7
|
SECONDARY outcome
Timeframe: until at least 386 deaths are documented in the clinical database.Population: Full Analysis Set (FAS) consisted of all randomized patients.
Overall survival (OS) was the key secondary endpoint and was defined as the time from date of randomization to the date of death due to any cause. If a patient was not known to have died, survival was censored on the date of last contact.
Outcome measures
| Measure |
Dovitinib + Best Supportive Care (BSC)
n=284 Participants
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib + BSC
n=286 Participants
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Overall Survival (OS)
|
11.1 Months
Interval 9.5 to 13.4
|
11.0 Months
Interval 8.6 to 13.5
|
SECONDARY outcome
Timeframe: Until disease progression or discontinuation of treatment due to unacceptable toxicityPopulation: Full Analysis Set (FAS) consisted of all randomized patients.
PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. The primary analysis for PFS (based on central review) was also to be repeated on FAS considering the Investigator assessments and using the same analytical conventions as the primary analysis.
Outcome measures
| Measure |
Dovitinib + Best Supportive Care (BSC)
n=284 Participants
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib + BSC
n=286 Participants
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Progression Free Survival (PFS) Per Investigator's Radiology Review
|
3.9 Months
Interval 3.7 to 5.1
|
3.9 Months
Interval 3.7 to 5.0
|
SECONDARY outcome
Timeframe: Until disease progression or discontinuation of treatment due to unacceptable toxicityPopulation: Full Analysis Set (FAS) consisted of all randomized patients.
Overall response rate (ORR) was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR). Best overall esponse (BOR) for each patient was determined from the sequence of overall (lesion) responses according to the following rules: CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. SD = at least one SD assessment (or better) \> 6 weeks after randomization (and not qualifying for CR or PR). PD = progression ≤ 17 weeks after randomization (and not qualifying for CR, PR or SD).
Outcome measures
| Measure |
Dovitinib + Best Supportive Care (BSC)
n=284 Participants
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib + BSC
n=286 Participants
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review
|
3.9 Percentage of Participants
|
3.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlierPopulation: Full Analysis Set (FAS) consited of all randomized patients.
Time to definitive worsening of Karnofsky performance status (KPS) was defined as the time from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier. Definitive worsening was defined as a definitive decrease in performance status by at least one Karnofsky category (i.e. at least 10 points less) compared to Baseline. Worsening was considered definitive if no later increase above the defined threshold was observed within the course of the study. A single measure reporting a decrease in Karnofsky performance status was sufficient to consider it as definitive only if it was the last one available for this patient. Time to definitive worsening of KPS was analyzed at the time of the final analysis for PFS.
Outcome measures
| Measure |
Dovitinib + Best Supportive Care (BSC)
n=284 Participants
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib + BSC
n=286 Participants
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Time to Definitive Worsening of Karnofsky Performance Status (KPS)
|
5.1 Months
Interval 3.8 to 6.5
|
5.7 Months
Interval 4.6 to 7.4
|
SECONDARY outcome
Timeframe: from date of randomization, at least 2 score unitsPopulation: Full Analysis Set (FAS) consisted of all randomized patients.
The Kidney Cancer Symptom Index - Disease Related Symptoms (FKSI-DRS) is a validated symptom scale used in studies of patients with kidney cancer. It includes 9-items that assess pain, bone pain, fatigue, lack of energy, shortness of breath, fevers, weight loss, coughing, and blood in urine and responses to each question are answered on a 5-point Likert-type scale ranging from 0 to 4 (e.g., 0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). FKSI-DRS scores range from 0 to 36, where higher scores correspond to better outcomes (eg, fewer symptoms).
Outcome measures
| Measure |
Dovitinib + Best Supportive Care (BSC)
n=284 Participants
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib + BSC
n=286 Participants
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Patient-reported Outcomes (PROs): Time to Deterioration of Functional Assessment of Cancer Therapy-Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) by at Least 2 Scores
|
4.9 Months
Interval 4.5 to 6.6
|
6.4 Months
Interval 5.5 to 7.7
|
SECONDARY outcome
Timeframe: from date of randomizationPopulation: Full Analysis Set (FAS) consisted of all randomized patients.
The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.
Outcome measures
| Measure |
Dovitinib + Best Supportive Care (BSC)
n=284 Participants
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib + BSC
n=286 Participants
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%
|
3.8 Months
Interval 3.2 to 4.6
|
5.6 Months
Interval 4.5 to 6.4
|
SECONDARY outcome
Timeframe: from date of randomizationPopulation: Full Analysis Set (FAS) consisted of all randomized patients.
The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.
Outcome measures
| Measure |
Dovitinib + Best Supportive Care (BSC)
n=284 Participants
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib + BSC
n=286 Participants
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%
|
3.7 Months
Interval 2.8 to 4.6
|
4.5 Months
Interval 3.7 to 5.5
|
SECONDARY outcome
Timeframe: Week 2 Day 5, Week 4 Day 5, Week 6 Day 5Population: Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one dose of dovitinib and had at least one evaluable post-Baseline dovitinib concentration measurement.
Predose concentrations of dovitinib were summarized by visit using PAS. All concentration data was listed by patient and time point using FAS. Mean pre-dose concentrations along with standard deviation (SD) was plotted over time if appropriate.
Outcome measures
| Measure |
Dovitinib + Best Supportive Care (BSC)
n=284 Participants
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib + BSC
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Pre-dose Concentration in Plasma in Dovitinib
Week 2 Day 5 (n: 205)
|
128.06 ng/ml
Standard Deviation 92.571
|
—
|
|
Pre-dose Concentration in Plasma in Dovitinib
Week 4 Day 5 (n: 202)
|
114.08 ng/ml
Standard Deviation 77.884
|
—
|
|
Pre-dose Concentration in Plasma in Dovitinib
Week 6 Day 5 (n: 170)
|
118.27 ng/ml
Standard Deviation 84.246
|
—
|
Adverse Events
Dovitinib
Serious events: 133 serious events
Other events: 268 other events
Deaths: 0 deaths
Sorafenib
Serious events: 112 serious events
Other events: 271 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dovitinib
n=280 participants at risk
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib
n=284 participants at risk
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Psychiatric disorders
APATHY
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.1%
3/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
TACHYCARDIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Endocrine disorders
HYPERCALCAEMIA OF MALIGNANCY
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Eye disorders
DIPLOPIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.5%
7/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
ABDOMINAL TENDERNESS
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
COLONIC FISTULA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.6%
10/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.4%
4/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
1.1%
3/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
FAECAL INCONTINENCE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
GASTRIC PERFORATION
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
GASTROINTESTINAL MOTILITY DISORDER
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
ILEUS
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
1.1%
3/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
LARGE INTESTINAL HAEMORRHAGE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
NAUSEA
|
2.1%
6/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.1%
3/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.1%
3/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
PNEUMOPERITONEUM
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMATOMA
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMORRHAGE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.1%
3/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
VOMITING
|
2.9%
8/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.1%
3/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
ASTHENIA
|
1.1%
3/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
2.1%
6/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
DEATH
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
FATIGUE
|
1.4%
4/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.8%
5/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
2.5%
7/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
4.9%
14/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
MALAISE
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
PAIN
|
1.1%
3/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.1%
3/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.1%
3/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
PYREXIA
|
2.5%
7/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.8%
5/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Hepatobiliary disorders
JAUNDICE CHOLESTATIC
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Immune system disorders
SERUM SICKNESS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
CYSTITIS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
EMPHYSEMATOUS CYSTITIS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
INFECTIVE GLOSSITIS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
PNEUMONIA
|
2.5%
7/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
2.8%
8/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.1%
3/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.4%
4/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
HYPOPROTEINAEMIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
LACTIC ACIDOSIS
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
AMYOTROPHY
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.1%
3/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.8%
5/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
2.5%
7/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DISORDER
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
MYOPATHY
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INFECTED NEOPLASM
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PLEURAL EFFUSION
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC PAIN
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OESOPHAGEAL CARCINOMA
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PERICARDIAL EFFUSION MALIGNANT
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
1.1%
3/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
APHASIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
CONVULSION
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
DIZZINESS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
EPILEPSY
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
HEMIPARESIS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
NEURALGIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
NEUROLOGICAL DECOMPENSATION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
PRESYNCOPE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
SCIATICA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
SYNCOPE
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
1.1%
3/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Psychiatric disorders
DELIRIUM
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Renal and urinary disorders
AZOTAEMIA
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.1%
3/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Renal and urinary disorders
URINARY BLADDER HAEMORRHAGE
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Reproductive system and breast disorders
GENITAL HAEMORRHAGE
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.7%
16/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
5.3%
15/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
HYDROTHORAX
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
3.6%
10/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
3.5%
10/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.1%
3/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.4%
4/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.1%
3/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
DIABETIC FOOT
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
TOXIC EPIDERMAL NECROLYSIS
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Vascular disorders
EMBOLISM
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Vascular disorders
PHLEBITIS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Vascular disorders
SHOCK
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Vascular disorders
THROMBOSIS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Vascular disorders
VASCULAR FRAGILITY
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.5%
7/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
2.5%
7/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
GENERALISED OEDEMA
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
ERYSIPELAS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
LUNG INFECTION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
MENINGITIS CRYPTOCOCCAL
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
SEPSIS
|
2.5%
7/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Injury, poisoning and procedural complications
CONTRAST MEDIA REACTION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
AMYLASE INCREASED
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
HAEMATOCRIT DECREASED
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
LIPASE INCREASED
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
TROPONIN INCREASED
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
WEIGHT DECREASED
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.4%
4/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.1%
6/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.8%
5/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
1.1%
3/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.35%
1/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
HYPOPHAGIA
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC COMPRESSION
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
EPIDURITIS
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
HYDROPNEUMOTHORAX
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.00%
0/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
Other adverse events
| Measure |
Dovitinib
n=280 participants at risk
Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
|
Sorafenib
n=284 participants at risk
Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
9.6%
27/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
9.9%
28/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
5.0%
14/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
2.8%
8/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Eye disorders
LACRIMATION INCREASED
|
6.8%
19/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
12.1%
34/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
13.0%
37/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
10.0%
28/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
8.1%
23/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
CONSTIPATION
|
17.5%
49/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
23.6%
67/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
DIARRHOEA
|
65.7%
184/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
44.4%
126/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
DRY MOUTH
|
8.2%
23/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
4.2%
12/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
10.7%
30/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
4.9%
14/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
NAUSEA
|
52.1%
146/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
28.5%
81/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
STOMATITIS
|
11.1%
31/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
18.7%
53/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Gastrointestinal disorders
VOMITING
|
42.9%
120/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
15.5%
44/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
ASTHENIA
|
22.5%
63/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
15.5%
44/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
FATIGUE
|
40.4%
113/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
33.1%
94/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
7.9%
22/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
6.3%
18/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
OEDEMA PERIPHERAL
|
9.3%
26/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
6.0%
17/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
General disorders
PYREXIA
|
14.3%
40/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
13.0%
37/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
8.9%
25/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
1.8%
5/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
8.9%
25/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
2.8%
8/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
LIPASE INCREASED
|
5.7%
16/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
3.9%
11/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Investigations
WEIGHT DECREASED
|
21.8%
61/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
30.6%
87/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
32.1%
90/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
33.8%
96/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
19.6%
55/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
0.70%
2/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
9.3%
26/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
9.2%
26/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
13.2%
37/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
11.3%
32/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
6.4%
18/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
8.5%
24/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
5.4%
15/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
2.1%
6/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.4%
15/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
4.6%
13/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
9.6%
27/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
6.0%
17/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
12.5%
35/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
10.2%
29/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
DIZZINESS
|
9.6%
27/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
2.5%
7/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
DYSGEUSIA
|
11.1%
31/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
2.8%
8/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Nervous system disorders
HEADACHE
|
9.3%
26/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
8.5%
24/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Psychiatric disorders
INSOMNIA
|
5.4%
15/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
6.7%
19/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
17.9%
50/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
16.9%
48/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
7.9%
22/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
8.8%
25/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
18.2%
51/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
16.9%
48/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.71%
2/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
21.5%
61/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
8.2%
23/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
2.1%
6/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
7.9%
22/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
9.2%
26/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.36%
1/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
5.3%
15/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
11.4%
32/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
40.1%
114/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.4%
15/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
10.6%
30/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Skin and subcutaneous tissue disorders
RASH
|
19.3%
54/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
16.5%
47/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
|
Vascular disorders
HYPERTENSION
|
19.3%
54/280
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
27.5%
78/284
570 patients randomized, 564 patients included in the Safety Set. AEs were reported based on this set which consisted of all patients who received at least 1 dose of study treatment. Patients were analyzed according to treatment actually received which was defined as the treatment the patient received at the first day of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER