Trial Outcomes & Findings for Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy (NCT NCT01852292)
NCT ID: NCT01852292
Last Updated: 2018-07-24
Results Overview
PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression per RECIST v. 1.1 or death due to any cause. If a patient has not progressed or died at the analysis cut-off date or when the patient receives further anti-neoplastic therapy, PFS was censored on the date of the last adequate tumor assessment before the earlier of the cut-off date or start of the further anti-neoplastic therapy date.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
157 participants
Primary outcome timeframe
4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years
Results posted on
2018-07-24
Participant Flow
Planned: 150; Analyzed: 158. Patients were randomized to receive treatment with buparlisib 100 mg daily (n=79) or placebo (n=79) in combination with paclitaxel.
158 patients randomized in a 1:1 ratio to treatment with buparlisib plus paclitaxel or placebo plus paclitaxel; stratification: number of prior lines of treatment in the recurrent/metastatic setting (1 vs.2) \& region of Investigator site (North America vs. Rest of the World). In this study, Not Completed = Discontinued study treatment per Protocol
Participant milestones
| Measure |
Buparlisib + Weekly Paclitaxel
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and weekly paclitaxel.
|
Buparlisib Matching Placebo + Paclitaxel
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and weekly paclitaxel.
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
79
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
79
|
79
|
Reasons for withdrawal
| Measure |
Buparlisib + Weekly Paclitaxel
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and weekly paclitaxel.
|
Buparlisib Matching Placebo + Paclitaxel
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and weekly paclitaxel.
|
|---|---|---|
|
Overall Study
Untreated - did not receive study drug
|
3
|
1
|
|
Overall Study
Death
|
9
|
8
|
|
Overall Study
Patient/guardian decision
|
8
|
4
|
|
Overall Study
Adverse Event
|
8
|
11
|
|
Overall Study
Physician Decision
|
6
|
2
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Non-compliance with study treatment
|
1
|
0
|
|
Overall Study
Study terminated by Sponsor
|
0
|
1
|
|
Overall Study
Progressive disease
|
42
|
52
|
Baseline Characteristics
The Full analysis set (FAS) includes all patients who were randomized to study treatment.
Baseline characteristics by cohort
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 Years
STANDARD_DEVIATION 9.44 • n=99 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
58.2 Years
STANDARD_DEVIATION 9.44 • n=107 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
58.1 Years
STANDARD_DEVIATION 9.41 • n=206 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
11 Participants
n=107 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
25 Participants
n=206 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
|
Sex: Female, Male
Male
|
65 Participants
n=99 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
68 Participants
n=107 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
133 Participants
n=206 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=99 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
0 Participants
n=107 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
3 Participants
n=206 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
|
Race/Ethnicity, Customized
East Asian
|
12 Participants
n=99 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
9 Participants
n=107 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
21 Participants
n=206 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
|
Race/Ethnicity, Customized
Southeast Asian
|
4 Participants
n=99 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
9 Participants
n=107 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
13 Participants
n=206 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
|
Race/Ethnicity, Customized
South Asian
|
6 Participants
n=99 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
5 Participants
n=107 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
11 Participants
n=206 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
|
Race/Ethnicity, Customized
Russian
|
7 Participants
n=99 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
4 Participants
n=107 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
11 Participants
n=206 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
|
Race/Ethnicity, Customized
Mixed ethnicity
|
1 Participants
n=99 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
2 Participants
n=107 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
3 Participants
n=206 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
|
Race/Ethnicity, Customized
Not reported
|
13 Participants
n=99 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
10 Participants
n=107 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
23 Participants
n=206 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=99 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
6 Participants
n=107 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
9 Participants
n=206 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
|
Race/Ethnicity, Customized
Other
|
30 Participants
n=99 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
34 Participants
n=107 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
64 Participants
n=206 Participants • The Full analysis set (FAS) includes all patients who were randomized to study treatment.
|
PRIMARY outcome
Timeframe: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 yearsPopulation: The Full analysis set (FAS) includes all patients who were randomized to study treatment.
PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression per RECIST v. 1.1 or death due to any cause. If a patient has not progressed or died at the analysis cut-off date or when the patient receives further anti-neoplastic therapy, PFS was censored on the date of the last adequate tumor assessment before the earlier of the cut-off date or start of the further anti-neoplastic therapy date.
Outcome measures
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Progression Free Survival (PFS) Per Investigator Assessment
|
4.63 months
Interval 3.52 to 5.32
|
3.45 months
Interval 2.17 to 3.71
|
SECONDARY outcome
Timeframe: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 yearsPopulation: The Full analysis set (FAS) includes all patients who were randomized to study treatment.
Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last contact.
Outcome measures
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Overall Survival (OS)
|
10.41 months
Interval 7.29 to 12.78
|
6.54 months
Interval 5.26 to 8.77
|
SECONDARY outcome
Timeframe: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 yearsPopulation: The Full analysis set (FAS) includes all patients who were randomized to study treatment.
ORR: percentage of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1. CR is defined as disappearance of all target lesions and any pathological lymph nodes must have a short axis of \<10 mm and the disappearance of all non-target lesions). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm).
Outcome measures
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Overall Response Rate (ORR) as Per Local Radiological Assessment
|
39.2 Percentage of participants
Interval 28.4 to 50.9
|
13.9 Percentage of participants
Interval 7.2 to 23.5
|
SECONDARY outcome
Timeframe: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 yearsPopulation: The Full analysis set (FAS) includes all patients who were randomized to study treatment.
TTR is the time from date of randomization until first documented response (CR or PR, which has to be confirmed subsequently) according to RECIST v1.1. CR is defined as disappearance of all target lesions and any pathological lymph nodes must have a short axis of \<10 mm and the disappearance of all non-target lesions). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm).
Outcome measures
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Time to Response (TTR) as Per Local Radiological Assessment
|
1.02 months
Interval 0.8 to 9.2
|
0.99 months
Interval 0.8 to 5.1
|
SECONDARY outcome
Timeframe: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 yearsPopulation: The Full analysis set (FAS) includes all patients who were randomized to study treatment.
DCR is the percentage of patients with a best overall response of CR, PR or stable disease (SD), according to RECIST v1.1. CR is defined as disappearance of all target lesions \& any pathological lymph nodes must have a short axis of \<10 mm \& the disappearance of all non-target lesions). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm). SD is defined as neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm\^2.
Outcome measures
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Disease Control Rate (DCR) as Per Local Radiological Assessment
|
72.2 Percentage of participants
Interval 60.9 to 81.7
|
69.6 Percentage of participants
Interval 58.2 to 79.5
|
SECONDARY outcome
Timeframe: 4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 yearsPopulation: The Full analysis set (FAS) includes all patients who were randomized to study treatment.
DoR is the time from the date of the first documented response (CR or PR, which had to be confirmed subsequently) to the date of the first radiologically documented disease progression or death due to disease according to RECIST v1.1 .
Outcome measures
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Duration of Response (DoR) as Per Local Investigator
|
3.06 months
Interval 2.1 to 9.6
|
4.17 months
Interval 2.7 to 5.6
|
SECONDARY outcome
Timeframe: Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 yearsPopulation: The Full analysis set (FAS) includes all patients who were randomized to study treatment.
A summary of EORTC-QLQ-C30 scores by time window. Time to deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen. Definitive Deterioration in global health status and symptoms was defined as a decrease in the subscale score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. If a patient had not had an event prior to analysis cut-off or start of another anticancer therapy, time to deterioration was censored at the date of the last quality of life (QoL) evaluation.
Outcome measures
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30
|
3.0 months
Interval 1.6 to 4.9
|
3.5 months
Interval 2.1 to 4.3
|
SECONDARY outcome
Timeframe: Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 yearsPopulation: The Full analysis set (FAS) includes all patients who were randomized to study treatment.
A summary of EORTC-QLQ-HN35 scores by time window. Time to deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen. Definitive Deterioration in global health status and symptoms was defined as an increase in the subscale score of at least 10% compared to baseline, with no later decrease above this threshold observed during the course of the study. If a patient had not had an event prior to analysis cut-off or start of another anticancer therapy, time to deterioration was censored at the date of the last quality of life (QoL) evaluation.
Outcome measures
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Head and Neck Cancer Symptoms Scales for Pain, Speech Problems, Swallowing and Sense Problems Per EORTC-QLQ-HN35
Pain Subscale
|
5.8 Months
Interval 4.2 to 7.3
|
5.3 Months
Interval 3.2 to 6.8
|
|
Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Head and Neck Cancer Symptoms Scales for Pain, Speech Problems, Swallowing and Sense Problems Per EORTC-QLQ-HN35
Speech problems
|
5.6 Months
Interval 4.1 to 6.9
|
4.2 Months
Interval 2.2 to 5.4
|
|
Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Head and Neck Cancer Symptoms Scales for Pain, Speech Problems, Swallowing and Sense Problems Per EORTC-QLQ-HN35
Swallowing
|
5.1 Months
Interval 3.7 to 7.2
|
4.6 Months
Interval 2.8 to 6.7
|
|
Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Head and Neck Cancer Symptoms Scales for Pain, Speech Problems, Swallowing and Sense Problems Per EORTC-QLQ-HN35
Sense Problems
|
5.1 Months
Interval 3.1 to 7.3
|
4.6 Months
Interval 2.9 to 6.5
|
SECONDARY outcome
Timeframe: Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15Population: Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn't vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile \& had evaluable full PK profile
To Characterize PK of buparlisib given in combination with paclitaxel for AUC0-24 (area under plasma concentration-time curve from time 0 to end of dosing interval of 24 hours) \& AUClast (AUC from time 0 to last measurable concentration sampling time).
Outcome measures
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for AUC0-24 and AUClast
AUC0-24 (n = 4)
|
25628.56 ng*hr/mL
Interval 13651.75 to 33375.1
|
—
|
|
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for AUC0-24 and AUClast
AUClast (n = 4)
|
25734.33 ng*hr/mL
Interval 13651.75 to 33306.37
|
—
|
SECONDARY outcome
Timeframe: Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15Population: Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn't vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile \& had evaluable full PK profile
To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for Cmax.
Outcome measures
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Cmax
|
1775.00 ng/mL
Interval 834.0 to 2180.0
|
—
|
SECONDARY outcome
Timeframe: Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15Population: Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn't vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile \& had evaluable full PK profile
To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for Tmax.
Outcome measures
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Tmax
|
2.42 hour (hr)
Interval 1.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15Population: Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn't vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile \& had evaluable full PK profile
To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for CL/F.
Outcome measures
| Measure |
Buparlisib + Paclitaxel
n=79 Participants
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for CL/F
|
4.14 L/hr
Interval 3.0 to 7.33
|
—
|
Adverse Events
Buparlisib + Paclitaxel
Serious events: 43 serious events
Other events: 76 other events
Deaths: 16 deaths
Buparlisib Matching Placebo + Paclitaxel
Serious events: 37 serious events
Other events: 75 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Buparlisib + Paclitaxel
n=76 participants at risk
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
n=78 participants at risk
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
3/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Cardiac disorders
Cardiac arrest
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Eye disorders
Blindness
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Aorto-oesophageal fistula
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Oesophagitis
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Oral cavity fistula
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Stomatitis
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Asthenia
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Face oedema
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Fatigue
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
General physical health deterioration
|
3.9%
3/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Non-cardiac chest pain
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Pain
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Pyrexia
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Hepatobiliary disorders
Hepatic failure
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Hepatobiliary disorders
Jaundice
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Anal abscess
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Bronchitis
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Candida sepsis
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Chest wall abscess
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Clostridium difficile colitis
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Erysipelas
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Herpes zoster
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Lung abscess
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Lung infection
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Pneumonia
|
7.9%
6/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
7.7%
6/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Post procedural infection
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Respiratory tract infection
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Sepsis
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Septic shock
|
3.9%
3/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Wound infection
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Investigations
Blood creatinine increased
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Investigations
Neutrophil count decreased
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Cachexia
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.9%
3/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.9%
3/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
3.9%
3/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
6.4%
5/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Dizziness
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Hypoaesthesia
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Neuralgia
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Paraplegia
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Somnolence
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Spinal cord compression
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Syncope
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Product Issues
Device connection issue
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Psychiatric disorders
Aggression
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Psychiatric disorders
Completed suicide
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Psychiatric disorders
Mental status changes
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Renal and urinary disorders
Renal failure
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Vascular disorders
Arterial rupture
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Vascular disorders
Hypotension
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Vascular disorders
Phlebitis
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
Other adverse events
| Measure |
Buparlisib + Paclitaxel
n=76 participants at risk
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
Buparlisib Matching Placebo + Paclitaxel
n=78 participants at risk
Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
38.2%
29/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
41.0%
32/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.2%
7/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
16.7%
13/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.3%
23/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
12.8%
10/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Abdominal pain
|
9.2%
7/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Constipation
|
18.4%
14/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
10.3%
8/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Diarrhoea
|
34.2%
26/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
16.7%
13/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Dysphagia
|
11.8%
9/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
6.4%
5/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Nausea
|
25.0%
19/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
16.7%
13/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Odynophagia
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Oral pain
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Stomatitis
|
30.3%
23/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
12.8%
10/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
19/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
14.1%
11/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Asthenia
|
26.3%
20/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
19.2%
15/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Face oedema
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Fatigue
|
40.8%
31/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
20.5%
16/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Non-cardiac chest pain
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Oedema peripheral
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
12.8%
10/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
General disorders
Pyrexia
|
15.8%
12/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
20.5%
16/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Pneumonia
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
7.7%
6/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Respiratory tract infection
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Investigations
Alanine aminotransferase increased
|
7.9%
6/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Investigations
Aspartate aminotransferase increased
|
7.9%
6/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
9.0%
7/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Investigations
Blood alkaline phosphatase increased
|
7.9%
6/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Investigations
Blood creatinine increased
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Investigations
Blood glucose increased
|
3.9%
3/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
6.4%
5/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.5%
8/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
9.0%
7/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Investigations
Neutrophil count decreased
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Investigations
Weight decreased
|
25.0%
19/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
11.5%
9/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Investigations
White blood cell count decreased
|
9.2%
7/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.3%
23/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
17.9%
14/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
61.8%
47/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
34.6%
27/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.6%
2/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
10.3%
8/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.2%
7/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
7.7%
6/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
7.7%
6/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.9%
3/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
6.4%
5/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
7.7%
6/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
6.4%
5/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.9%
6/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
9.0%
7/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
6.4%
5/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Dizziness
|
7.9%
6/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
7.7%
6/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Dysgeusia
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Headache
|
18.4%
14/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
7.7%
6/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Neuropathy peripheral
|
7.9%
6/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
23.1%
18/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Paraesthesia
|
10.5%
8/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
11.5%
9/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.9%
6/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Psychiatric disorders
Anxiety
|
17.1%
13/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
11.5%
9/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Psychiatric disorders
Depression
|
17.1%
13/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
9.0%
7/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Psychiatric disorders
Insomnia
|
13.2%
10/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
7.7%
6/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Psychiatric disorders
Mood altered
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
6.4%
5/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.4%
17/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
23.1%
18/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.9%
3/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
8/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
16.7%
13/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.2%
7/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.3%
1/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
9.0%
7/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
7.7%
6/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.6%
24/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
19.2%
15/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
1.3%
1/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.5%
8/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.5%
8/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
2.6%
2/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
5.1%
4/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.3%
4/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
0.00%
0/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
8/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.4%
14/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
14.1%
11/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.6%
5/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
3.8%
3/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
|
Vascular disorders
Hypertension
|
14.5%
11/76 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
7.7%
6/78 • Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3.5 years.
AEs, SAEs based on Safety Set: all pts who received at least 1 dose of study trtmnt \& had at least 1 post-baseline safety assessment. Pts analyzed according to study trtmnt actually received, defined as trtmnt pt received on 1st day of study trtmnt
|
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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER