Trial Outcomes & Findings for Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX) (NCT NCT00148798)
NCT ID: NCT00148798
Last Updated: 2014-06-25
Results Overview
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1861 participants
Primary outcome timeframe
Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Results posted on
2014-06-25
Participant Flow
First/last subject (informed consent): October 2004/January 2006. Clinical data cut-off: 18 July 2007. Last subject completed 16 May 2012. Subjects randomized at 155 centers; Asia/Australia: 21; Europe: 120; South America: 14.
Enrolled: 1,861 after consent to epidermal growth factor receptor (EGFR) assessment; 603 excluded (mainly non-fulfillment of inclusion or exclusion criteria). 1,258 screened for eligibility after consent for study procedures; 143 excluded (mainly non-fulfillment of inclusion or exclusion criteria). 1,125 subjects randomized.
Participant milestones
| Measure |
Cetuximab Plus Chemotherapy
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Chemotherapy Alone
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
|---|---|---|
|
Overall Study
STARTED
|
557
|
568
|
|
Overall Study
COMPLETED
|
557
|
568
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)
Baseline characteristics by cohort
| Measure |
Cetuximab Plus Chemotherapy
n=557 Participants
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Chemotherapy Alone
n=568 Participants
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Total
n=1125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=99 Participants
|
60 years
n=107 Participants
|
59 years
n=206 Participants
|
|
Age, Customized
<18 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Age, Customized
Between 18 and 65 years
|
385 participants
n=99 Participants
|
389 participants
n=107 Participants
|
774 participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
172 participants
n=99 Participants
|
179 participants
n=107 Participants
|
351 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=99 Participants
|
163 Participants
n=107 Participants
|
335 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
385 Participants
n=99 Participants
|
405 Participants
n=107 Participants
|
790 Participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=99 Participants
|
23 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Region of Enrollment
Hong Kong
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Singapore
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Region of Enrollment
Korea, Republic of
|
28 participants
n=99 Participants
|
26 participants
n=107 Participants
|
54 participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
21 participants
n=99 Participants
|
22 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
9 participants
n=99 Participants
|
7 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=99 Participants
|
10 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Region of Enrollment
Czech Republic
|
12 participants
n=99 Participants
|
17 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Region of Enrollment
France
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
91 participants
n=99 Participants
|
88 participants
n=107 Participants
|
179 participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
21 participants
n=99 Participants
|
23 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Region of Enrollment
Ireland
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
59 participants
n=99 Participants
|
50 participants
n=107 Participants
|
109 participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
23 participants
n=99 Participants
|
16 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
Region of Enrollment
Slovakia
|
8 participants
n=99 Participants
|
12 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
16 participants
n=99 Participants
|
13 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Region of Enrollment
Sweden
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
Switzerland
|
10 participants
n=99 Participants
|
6 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Region of Enrollment
Turkey
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
23 participants
n=99 Participants
|
21 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Region of Enrollment
Ukraine
|
56 participants
n=99 Participants
|
71 participants
n=107 Participants
|
127 participants
n=206 Participants
|
|
Region of Enrollment
Chile
|
10 participants
n=99 Participants
|
16 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
18 participants
n=99 Participants
|
23 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
9 participants
n=99 Participants
|
8 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
48 participants
n=99 Participants
|
51 participants
n=107 Participants
|
99 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007Population: ITT
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=557 Participants
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Chemotherapy Alone
n=568 Participants
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
|---|---|---|
|
Overall Survival Time (OS)
|
11.3 months
Interval 9.4 to 12.4
|
10.1 months
Interval 9.1 to 10.9
|
SECONDARY outcome
Timeframe: Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007Population: ITT
Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=557 Participants
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Chemotherapy Alone
n=568 Participants
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
|---|---|---|
|
Progression-free Survival Time
|
4.8 months
Interval 4.2 to 5.3
|
4.8 months
Interval 4.4 to 5.4
|
SECONDARY outcome
Timeframe: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=557 Participants
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Chemotherapy Alone
n=568 Participants
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
|---|---|---|
|
Best Overall Response Rate
|
36.4 percentage of participants
Interval 32.4 to 40.6
|
29.2 percentage of participants
Interval 25.5 to 33.2
|
SECONDARY outcome
Timeframe: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007Population: ITT
The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=557 Participants
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Chemotherapy Alone
n=568 Participants
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
|---|---|---|
|
Disease Control Rate
|
72.5 percentage of participants
Interval 68.6 to 76.2
|
71.5 percentage of participants
Interval 67.6 to 75.2
|
SECONDARY outcome
Timeframe: at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007Population: 670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 278/274; cycle 3 184/153; 6 month 102/96
Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=348 Participants
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Chemotherapy Alone
n=322 Participants
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
|---|---|---|
|
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
At baseline
|
45.72 scores on a scale
Standard Error 2.164
|
46.36 scores on a scale
Standard Error 2.138
|
|
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
At cycle 3
|
48.33 scores on a scale
Standard Error 2.325
|
51.55 scores on a scale
Standard Error 2.464
|
|
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
At month 6
|
54.71 scores on a scale
Standard Error 2.729
|
52.92 scores on a scale
Standard Error 2.787
|
SECONDARY outcome
Timeframe: at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007Population: 670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 280/275; cycle 3 185/153; 6 month 101/97
Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=348 Participants
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Chemotherapy Alone
n=322 Participants
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
|---|---|---|
|
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
At baseline
|
66.17 scores on a scale
Standard Error 2.836
|
64.73 scores on a scale
Standard Error 2.825
|
|
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
At cycle 3
|
58.05 scores on a scale
Standard Error 2.995
|
67.13 scores on a scale
Standard Error 3.138
|
|
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
At month 6
|
67.36 scores on a scale
Standard Error 3.449
|
66.47 scores on a scale
Standard Error 3.515
|
SECONDARY outcome
Timeframe: Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011.
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=454 Participants
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Chemotherapy Alone
n=298 Participants
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
|---|---|---|
|
A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations
|
223.1 ug/mL
Standard Deviation 64.6
|
51.5 ug/mL
Standard Deviation 33.1
|
SECONDARY outcome
Timeframe: time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007Population: Safety Population
Please refer to Adverse Events section for further details
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=548 Participants
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Chemotherapy Alone
n=562 Participants
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
|---|---|---|
|
Safety - Number of Patients Experiencing Any Adverse Event
|
545 participants
|
549 participants
|
Adverse Events
Cetuximab Plus Chemotherapy
Serious events: 325 serious events
Other events: 532 other events
Deaths: 0 deaths
Chemotherapy Alone
Serious events: 244 serious events
Other events: 537 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab Plus Chemotherapy
n=548 participants at risk
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Chemotherapy Alone
n=562 participants at risk
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
11/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.1%
12/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.73%
4/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
17.5%
96/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
11.9%
67/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.7%
15/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.4%
8/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.6%
47/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.9%
33/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.73%
4/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.71%
4/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Cardiac failure
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Cardiac failure acute
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Cardiac tamponade
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Cardiogenic shock
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.55%
3/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.53%
3/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Left ventricular failure
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Microvascular angina
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Myocardial infarction
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Palpitations
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Pericardial effusion
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
6/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.4%
8/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Colitis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Constipation
|
0.91%
5/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.1%
6/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
8/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.89%
5/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Dysphagia
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Enteritis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Haematemesis
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
6/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.89%
5/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Odynophagia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Eye disorders
Retinal detachment
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.55%
3/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
16/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.5%
14/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Asthenia
|
0.73%
4/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Chest discomfort
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Chest pain
|
1.3%
7/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.1%
6/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Death
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Drug interaction
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Fatigue
|
0.91%
5/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Gait disturbance
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
General physical health deterioration
|
4.0%
22/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.71%
4/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Injection site reaction
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Malaise
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Mucosal inflammation
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Multi-organ failure
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Oedema
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Pain
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Performance status decreased
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Pyrexia
|
2.9%
16/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.1%
6/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Sudden death
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Immune system disorders
Anaphylactic reaction
|
0.55%
3/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Immune system disorders
Anaphylactic shock
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Immune system disorders
Drug hypersensitivity
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Immune system disorders
Hypersensitivity
|
0.91%
5/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Immune system disorders
Serum sickness
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Bacteraemia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Brain abscess
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Bronchitis
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Bronchitis bacterial
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Bronchopneumonia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Catheter related infection
|
0.55%
3/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Cellulitis
|
0.73%
4/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Central line infection
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Febrile infection
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Gangrene
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Infection
|
0.55%
3/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Laryngitis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Laryngotracheo bronchitis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Lobar pneumonia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.73%
4/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Lung abscess
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Lung infection
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Nasopharyngitis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Neutropenic infection
|
1.6%
9/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.89%
5/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Neutropenic sepsis
|
1.6%
9/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.89%
5/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Parotitis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Pharyngitis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Pneumonia
|
3.5%
19/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.3%
13/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Pneumonia necrotising
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Pyothorax
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Respiratory tract infection
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Sepsis
|
1.6%
9/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.53%
3/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Septic shock
|
1.1%
6/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Staphylococcal infection
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Urinary tract infection
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Wound infection
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
Aspiration bronchial
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
Blood creatinine increased
|
0.91%
5/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.71%
4/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
Blood urea increased
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
C-reactive protein increased
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
Karnofsky scale worsened
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
Neutrophil count decreased
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
Pulmonary arterial pressure increased
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
Weight decreased
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
White blood cell count decreased
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.73%
4/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
12/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.6%
9/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.73%
4/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to heart
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.55%
3/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.89%
5/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Cognitive disorder
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Coma
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Convulsion
|
0.55%
3/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Coordination abnormal
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Dizziness
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Headache
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Hemiplegia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Horner's syndrome
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Monoparesis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Neuralgia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Somnolence
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Speech disorder
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Spinal cord compression
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Syncope
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Syncope vasovagal
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Transverse sinus thrombosis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Psychiatric disorders
Confusional state
|
0.91%
5/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.71%
4/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Psychiatric disorders
Depression
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Renal and urinary disorders
Renal colic
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Renal and urinary disorders
Renal failure
|
1.1%
6/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.1%
6/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Renal and urinary disorders
Renal failure acute
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Renal and urinary disorders
Renal impairment
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
18/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.3%
13/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.55%
3/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.1%
6/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.71%
4/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.53%
3/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.6%
20/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.3%
13/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.6%
14/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.6%
9/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.73%
4/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Arterial thrombosis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Axillary vein thrombosis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
9/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.53%
3/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Embolism
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Haematoma
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Hypertension
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Hypertensive crisis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Hypotension
|
0.91%
5/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Iliac artery occlusion
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Peripheral ischaemia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Shock
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Superior vena caval occlusion
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Thrombosis
|
0.36%
2/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Vascular fragility
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Vasculitis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Venous thrombosis
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Visceral arterial ischaemia
|
0.18%
1/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
Other adverse events
| Measure |
Cetuximab Plus Chemotherapy
n=548 participants at risk
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
Chemotherapy Alone
n=562 participants at risk
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Safety population: includes all treated subjects.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
55.1%
302/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
57.7%
324/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
Anaemia
|
41.2%
226/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
47.0%
264/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
Leukopenia
|
32.1%
176/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
27.6%
155/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.6%
36/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.7%
32/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.2%
23/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.3%
30/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.9%
49/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
9.8%
55/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Eye disorders
Conjunctivitis
|
6.0%
33/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.1%
6/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Nausea
|
53.1%
291/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
53.9%
303/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Vomiting
|
39.1%
214/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
40.0%
225/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Constipation
|
37.2%
204/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
33.6%
189/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.0%
126/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
18.3%
103/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Stomatitis
|
15.5%
85/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.8%
27/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.1%
72/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
12.8%
72/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.4%
68/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
9.8%
55/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.2%
45/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
6.6%
37/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
Dysphagia
|
5.7%
31/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.2%
7/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Fatigue
|
36.9%
202/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
32.2%
181/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Pyrexia
|
20.4%
112/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
14.2%
80/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Asthenia
|
16.4%
90/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
17.1%
96/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Chest pain
|
12.8%
70/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
12.5%
70/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Mucosal inflammation
|
10.2%
56/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.1%
23/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Chills
|
6.4%
35/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.4%
19/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Injection site reaction
|
6.0%
33/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.2%
29/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
Oedema peripheral
|
5.3%
29/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
6.9%
39/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Paronychia
|
8.4%
46/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
37/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.8%
16/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
Weight decreased
|
13.7%
75/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
8.9%
50/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
Blood creatinine increased
|
8.6%
47/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
8.7%
49/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
White blood cell count decreased
|
6.6%
36/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.6%
26/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Anorexia
|
38.0%
208/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
35.9%
202/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.7%
75/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
8.7%
49/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.9%
54/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.8%
27/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.7%
31/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.8%
10/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.7%
53/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.7%
32/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
39/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
7.8%
44/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
39/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
6.6%
37/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
30/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.9%
22/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.3%
29/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.0%
28/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Dizziness
|
15.0%
82/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
10.1%
57/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Headache
|
14.4%
79/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
10.7%
60/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.9%
49/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
8.2%
46/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Paraesthesia
|
7.3%
40/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.8%
27/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
Dysgeusia
|
5.7%
31/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.9%
33/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Psychiatric disorders
Insomnia
|
10.6%
58/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
8.7%
49/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.4%
101/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
16.9%
95/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.7%
97/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
14.2%
80/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.2%
45/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.3%
24/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.0%
33/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.5%
14/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.7%
31/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.6%
20/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.5%
30/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.7%
15/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
Rash
|
45.4%
249/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.0%
17/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.5%
107/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
19.0%
107/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.9%
76/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.6%
9/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
13.7%
75/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.18%
1/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.7%
64/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.3%
13/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.9%
38/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.36%
2/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
5.5%
30/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.00%
0/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Phlebitis
|
8.8%
48/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
7.8%
44/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Hypertension
|
7.3%
40/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.8%
27/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
Hypotension
|
7.1%
39/548 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.1%
23/562 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER