Trial Outcomes & Findings for Cetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME) (NCT NCT00122460)
NCT ID: NCT00122460
Last Updated: 2014-07-23
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
442 participants
Primary outcome timeframe
time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007
Results posted on
2014-07-23
Participant Flow
First/last subject(informed consent): 14Dec 2004/28 Dec2005. Clinical cut-off: 12 Mar 2007. 80 centers in Europe: Austria (3), Belgium (5), Czech Republic (2), France (12),Germany (8), Hungary (4), Italy (5), Netherlands (4), Poland (5), Portugal (3), Russia (4), Slovakia (2), Spain (9), Sweden (3), Switzerland (3), UK (4), and Ukraine (4).
477 subjects screened. 41 ineligible for treatment at end of screening (inclusion/exclusion criteria not fulfilled (30),death (3),consent withdrawal(3), symptomatic deterioration(2),non-compliance with timelines(1),refusal to continue study procedures (1), missing (1).436 eligible for treatment; however 6 of the ineligible patients were randomized
Participant milestones
| Measure |
Cetuximab Plus Chemotherapy
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
222
|
220
|
|
Overall Study
COMPLETED
|
215
|
219
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
Cetuximab Plus Chemotherapy
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Overall Study
investigational study phase ongoing
|
7
|
1
|
Baseline Characteristics
Cetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME)
Baseline characteristics by cohort
| Measure |
Cetuximab Plus Chemotherapy
n=222 Participants
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
n=220 Participants
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Total
n=442 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
183 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
399 Participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
38 participants
n=5 Participants
|
41 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
France
|
45 participants
n=5 Participants
|
31 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
19 participants
n=5 Participants
|
24 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
18 participants
n=5 Participants
|
14 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007Population: Primary analysis on Intent to Treat (ITT) population (allocation to treatment groups as randomized). Analysis performed after the required number of 340 deaths had been reported (expected effect: 36% increase in median survival time, power = 80%, alpha=5% (two-sided)). The Clinical cut-off date was 12 Mar 2007.
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=222 Participants
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
n=220 Participants
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Overall Survival Time (OS)
|
10.1 months
Interval 8.6 to 11.2
|
7.4 months
Interval 6.4 to 8.3
|
SECONDARY outcome
Timeframe: time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007Population: Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.
Duration from randomization until radiological progression according to investigator (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=222 Participants
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
n=220 Participants
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Progression-free Survival Time (PFS)
|
5.6 months
Interval 5.0 to 6.0
|
3.3 months
Interval 2.9 to 4.3
|
SECONDARY outcome
Timeframe: evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007Population: Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments according to investigator (based on modified WHO criteria).
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=222 Participants
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
n=220 Participants
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Best Overall Response
|
35.6 percentage of participants
Interval 29.3 to 42.3
|
19.5 percentage of participants
Interval 14.5 to 25.4
|
SECONDARY outcome
Timeframe: evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007Population: Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.
The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments according to investigator (based on modified WHO criteria).
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=222 Participants
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
n=220 Participants
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Disease Control
|
81.1 percentage of participants
Interval 75.3 to 86.0
|
60.0 percentage of participants
Interval 53.2 to 66.5
|
SECONDARY outcome
Timeframe: Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007Population: Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.
Time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 60 days of last tumor assessment). Patients without event are censored on the date of last tumor assessment.
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=222 Participants
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
n=220 Participants
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Time to Treatment Failure
|
4.8 months
Interval 4.0 to 5.6
|
3.0 months
Interval 2.8 to 3.4
|
SECONDARY outcome
Timeframe: time from first assessment of Complete Response or Partial Response to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007Population: Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.
Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment). Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=222 Participants
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
n=220 Participants
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Duration of Response
|
5.6 months
Interval 4.7 to 6.0
|
4.7 months
Interval 3.5 to 5.9
|
SECONDARY outcome
Timeframe: at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007Population: Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab+chemotherapy/chemotherapy alone): Baseline: 121/106; Cycle3:87/67; Month6:48/22
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=152 Participants
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
n=139 Participants
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
At baseline
|
50.74 scores on a scale
Standard Error 3.519
|
45.15 scores on a scale
Standard Error 3.745
|
|
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
At cycle 3
|
52.68 scores on a scale
Standard Error 3.724
|
45.48 scores on a scale
Standard Error 4.153
|
|
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
Month 6
|
55.30 scores on a scale
Standard Error 4.282
|
42.49 scores on a scale
Standard Error 5.959
|
SECONDARY outcome
Timeframe: at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007Population: Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab +chemotherapy/chemotherapy alone): Baseline:123/109; Cycle3:87/69; Month6:48/23
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 social functioning.
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=152 Participants
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
n=139 Participants
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
At baseline
|
62.14 scores on a scale
Standard Error 4.459
|
62.05 scores on a scale
Standard Error 4.730
|
|
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
At cycle 3
|
64.64 scores on a scale
Standard Error 4.663
|
60.67 scores on a scale
Standard Error 5.176
|
|
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
Month 6
|
61.27 scores on a scale
Standard Error 5.347
|
65.72 scores on a scale
Standard Error 7.122
|
SECONDARY outcome
Timeframe: time from first dose up to 30 after last dose of study treatment, reported between day of first dose of study treatment, 22 Dec 2004, until cut-off date 12 Mar 2007Population: Safety population
Please refer to Adverse Events section for further details
Outcome measures
| Measure |
Cetuximab Plus Chemotherapy
n=219 Participants
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
n=215 Participants
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Safety - Number of Patients Experiencing Any Adverse Event
|
218 participants
|
208 participants
|
Adverse Events
Cetuximab Plus Chemotherapy
Serious events: 110 serious events
Other events: 214 other events
Deaths: 0 deaths
Chemotherapy Alone
Serious events: 102 serious events
Other events: 198 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab Plus Chemotherapy
n=219 participants at risk
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
n=215 participants at risk
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Infections and infestations
Pneumococcal sepsis
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
4.6%
10/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.9%
4/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Lymph gland infection
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Meningitis
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.8%
4/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Abscess neck
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 sepsis
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Erysipelas
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.9%
4/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.3%
7/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Hepatomegaly
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 staphylococcal
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Salmonella sepsis
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.7%
6/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.4%
3/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Thrombophlebitis septic
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Feeding tube complication
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Gastrostomy failure
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Hip fracture
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Post procedural haemorrhage
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Creatinine renal clearance decreased
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Haemoglobin
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Haemoglobin decreased
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.9%
4/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Neurological examination abnormal
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Oxygen saturation decreased
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Platelet count decreased
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Transaminases increased
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Urine electrolytes decreased
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
3/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.4%
3/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Cachexia
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
4.1%
9/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
3/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Hypercalcaemia
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
3/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Hypernatraemia
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Hyperuricaemia
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Hypoalbuminaemia
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.8%
4/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.8%
4/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Hypophosphataemia
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Hypovolaemia
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Malnutrition
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Bursitis
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Fistula
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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)
Bladder cancer
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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)
Infected neoplasm
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 associated fever
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 haemorrhage
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.3%
7/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Brain oedema
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
3/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Intracranial hypotension
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Ischaemic stroke
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
3/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
3/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Suicide attempt
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Haematuria
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.4%
3/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
3/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Bronchial obstruction
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.8%
4/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.1%
11/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 at rest
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.4%
3/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Hydropneumothorax
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Laryngeal oedema
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 disorder
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Pneumonia aspiration
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Productive cough
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 thrombosis
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
5/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Stridor
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 toxicity
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Surgical and medical procedures
Gastrostomy tube insertion
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Surgical and medical procedures
Medical device removal
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Aortic aneurysm
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Aortic aneurysm rupture
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Haemorrhage
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Ischaemia
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 haemorrhagic
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Wound haemorrhage
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.3%
5/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.7%
10/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Coagulopathy
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
3.7%
8/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.2%
9/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Haemolysis
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Leukocytosis
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
5/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Lymph node pain
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.4%
3/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.7%
10/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.8%
4/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
6/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 coronary syndrome
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 unstable
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Coronary artery thrombosis
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Keratitis
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Aphagia
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.8%
4/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Duodenal ulcer perforation
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Oral pain
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Rectal haemorrhage
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Stress ulcer
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Subileus
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Upper gastrointestinal haemorrhage
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.3%
5/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.9%
4/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.91%
2/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Face oedema
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.8%
4/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.3%
5/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Hyperthermia
|
0.00%
0/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.3%
5/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
6/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.46%
1/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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=219 participants at risk
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
Chemotherapy Alone
n=215 participants at risk
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
42.0%
92/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
51.6%
111/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
37.9%
83/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
35.8%
77/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
21.0%
46/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
22.3%
48/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
18.7%
41/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
14.9%
32/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Lymphopenia
|
7.3%
16/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
6.0%
13/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
9.6%
21/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
54.3%
119/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
46.5%
100/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
38.4%
84/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
36.7%
79/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
25.6%
56/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
15.3%
33/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
21.9%
48/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
20.0%
43/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
14.2%
31/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
13.0%
28/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
9.6%
21/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
8.8%
19/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
6.8%
15/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.3%
7/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
5.9%
13/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.3%
7/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
25.6%
56/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
21.9%
47/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
22.8%
50/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
17.7%
38/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
22.4%
49/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
20.5%
44/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
21.9%
48/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
23/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
5.0%
11/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.93%
2/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
8.7%
19/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
18.7%
41/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
14.0%
30/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Platelet count decreased
|
5.9%
13/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.3%
7/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
5.0%
11/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
6.0%
13/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Haemoglobin decreased
|
4.1%
9/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.1%
11/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
24.7%
54/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
14.4%
31/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
11.9%
26/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.7%
10/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
11.4%
25/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
7.0%
15/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
10.0%
22/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.1%
11/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
5.5%
12/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
7.9%
17/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
5.5%
12/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.1%
11/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
8.7%
19/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
8.8%
19/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
9.1%
20/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
7.0%
15/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
6.4%
14/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.7%
8/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
4.6%
10/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.1%
11/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Insomnia
|
9.1%
20/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.3%
7/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
10.0%
22/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
8.8%
19/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
8.7%
19/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
8.8%
19/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Productive cough
|
5.5%
12/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.6%
12/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
27.9%
61/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.9%
4/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
21.9%
48/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
14.6%
32/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
13.7%
30/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.47%
1/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
12.3%
27/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
7.0%
15/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
8.2%
18/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
Exfoliative rash
|
7.8%
17/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 toxicity
|
5.9%
13/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
6.8%
15/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.7%
10/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
6.4%
14/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.2%
9/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
5.0%
11/219 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
5/215 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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