Trial Outcomes & Findings for Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC) (NCT NCT00125034)
NCT ID: NCT00125034
Last Updated: 2014-08-07
Results Overview
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 (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
344 participants
Primary outcome timeframe
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006
Results posted on
2014-08-07
Participant Flow
First \& last subject randomized: 27 Jul 2005 \& 8 Mar 2006, respectively. Primary outcome and disease control rate cut-off dates 4 Aug 2006, others: 1 Mar 2007; except overall survival, KRAS overall survival and KRAS progression-free survival outcomes, metastatic surgery outcome and adverse events: 30 Nov 2008.
629 subjects were prescreened, of whom 344 subjects were randomised. 338 subjects (Safety Population) received treatment. One subject was erroneously randomized, and was excluded from the ITT population (337 subjects).
Participant milestones
| Measure |
Cetuximab Plus FOLFOX-4
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
FOLFOX-4 Alone
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Overall Study
STARTED
|
170
|
168
|
|
Overall Study
COMPLETED
|
170
|
168
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC)
Baseline characteristics by cohort
| Measure |
Cetuximab Plus FOLFOX-4
n=169 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
FOLFOX-4 Alone
n=168 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Total
n=337 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
96 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
205 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
73 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Age, Continuous
|
62.0 years
n=99 Participants
|
60.0 years
n=107 Participants
|
61.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
181 Participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
19 participants
n=99 Participants
|
16 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Region of Enrollment
Ukraine
|
24 participants
n=99 Participants
|
25 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
16 participants
n=99 Participants
|
9 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
25 participants
n=99 Participants
|
24 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
8 participants
n=99 Participants
|
6 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Region of Enrollment
France
|
3 participants
n=99 Participants
|
12 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
12 participants
n=99 Participants
|
6 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
30 participants
n=99 Participants
|
31 participants
n=107 Participants
|
61 participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
18 participants
n=99 Participants
|
13 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=99 Participants
|
22 participants
n=107 Participants
|
36 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006Population: Primary analysis on the Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).
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 (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.
Outcome measures
| Measure |
FOLFOX-4 Alone
n=168 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=169 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Best Overall Response Rate - Independent Review Committee (IRC)
|
35.7 percentage of participants
Interval 28.5 to 43.5
|
45.6 percentage of participants
Interval 37.9 to 53.4
|
SECONDARY outcome
Timeframe: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007Population: KRAS Wild-Type population
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 (based on modified WHO criteria) as assessed by an IRC.
Outcome measures
| Measure |
FOLFOX-4 Alone
n=97 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=82 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)
|
34.0 percentage of participants
Interval 24.7 to 44.3
|
57.3 percentage of participants
Interval 45.9 to 68.2
|
SECONDARY outcome
Timeframe: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007Population: KRAS Mutant population
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 (based on modified WHO criteria) as assessed by an IRC.
Outcome measures
| Measure |
FOLFOX-4 Alone
n=59 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=77 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Best Overall Response Rate (KRAS Mutant Population)
|
52.5 percentage of participants
Interval 39.1 to 65.7
|
33.8 percentage of participants
Interval 23.4 to 45.5
|
SECONDARY outcome
Timeframe: Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007Population: Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).
Duration from randomization until radiological progression as assessed by an IRC (based on modified 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 |
FOLFOX-4 Alone
n=168 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=169 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Progression-free Survival Time
|
7.2 months
Interval 6.0 to 7.8
|
7.2 months
Interval 5.6 to 7.7
|
SECONDARY outcome
Timeframe: Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008Population: KRAS Wild-Type population
Duration from randomization until radiological progression as assessed by an IRC (based on modified 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 |
FOLFOX-4 Alone
n=97 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=82 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Progression-free Survival Time (KRAS Wild-Type Population)
|
7.2 months
Interval 5.6 to 7.4
|
8.3 months
Interval 7.2 to 12.0
|
SECONDARY outcome
Timeframe: Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008Population: KRAS Mutant population
Duration from randomization until radiological progression as assessed by an IRC (based on modified 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 |
FOLFOX-4 Alone
n=59 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=77 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Progression-free Survival Time (KRAS Mutant Population)
|
8.6 months
Interval 6.5 to 9.4
|
5.5 months
Interval 4.0 to 7.3
|
SECONDARY outcome
Timeframe: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008Population: Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).
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 |
FOLFOX-4 Alone
n=168 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=169 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Overall Survival Time
|
18.0 months
Interval 16.7 to 21.8
|
18.3 months
Interval 14.8 to 20.4
|
SECONDARY outcome
Timeframe: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008Population: KRAS Wild-Type population
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 |
FOLFOX-4 Alone
n=97 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=82 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Overall Survival Time (KRAS Wild-Type Population)
|
18.5 months
Interval 16.4 to 22.6
|
22.8 months
Interval 19.3 to 25.9
|
SECONDARY outcome
Timeframe: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008Population: KRAS Mutant population
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 |
FOLFOX-4 Alone
n=59 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=77 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Overall Survival Time (KRAS Mutant Population)
|
17.5 months
Interval 14.7 to 24.8
|
13.4 months
Interval 10.5 to 17.7
|
SECONDARY outcome
Timeframe: Time from first dose up to 30 days after the last dose of study treatment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008Population: Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).
No residual tumor after on-study surgery for metastases.
Outcome measures
| Measure |
FOLFOX-4 Alone
n=168 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=169 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Participants With No Residual Tumor After Metastatic Surgery
|
4 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006Population: Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).
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 as assessed by IRC (based on modified WHO criteria).
Outcome measures
| Measure |
FOLFOX-4 Alone
n=168 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=169 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Disease Control Rate (Cut Off Date 4 August 2006)
|
81.0 percentage of participants
Interval 74.2 to 86.6
|
85.2 percentage of participants
Interval 78.9 to 90.2
|
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, 27 Jul 2005, until cut-off date 01 Mar 2007Population: Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).
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 |
FOLFOX-4 Alone
n=168 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=169 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Duration of Response
|
5.7 months
Interval 5.4 to 7.7
|
9.0 months
Interval 5.9 to 11.1
|
SECONDARY outcome
Timeframe: time from first dose up to 30 after last dose of study treatment, reported between day of first patient dose of study treatment, 27 Jul 2005, until cut-off date 30 Nov 2008Population: Safety Population
Please refer to Adverse Events section for further details
Outcome measures
| Measure |
FOLFOX-4 Alone
n=168 Participants
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
Cetuximab Plus FOLFOX-4
n=170 Participants
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Safety - Number of Patients Experiencing Any Adverse Event
|
165 participants
|
170 participants
|
Adverse Events
Cetuximab Plus FOLFOX-4
Serious events: 61 serious events
Other events: 170 other events
Deaths: 0 deaths
FOLFOX-4 Alone
Serious events: 43 serious events
Other events: 165 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab Plus FOLFOX-4
n=170 participants at risk
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
FOLFOX-4 Alone
n=168 participants at risk
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.4%
4/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.8%
3/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.8%
3/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.2%
2/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.4%
4/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.0%
5/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ASCITES
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.2%
2/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 PERFORATION
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.4%
4/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
1.8%
3/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
LARGE INTESTINAL OBSTRUCTION
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
PANCREATITIS
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
PERITONITIS
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 STENOSIS
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.4%
4/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.8%
3/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
FATIGUE
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
INJECTION SITE REACTION
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
MASS
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
OBSTRUCTION
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
PYREXIA
|
2.4%
4/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.4%
4/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
BILE DUCT STONE
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CHOLANGITIS
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
HEPATORENAL SYNDROME
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
JAUNDICE
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.9%
5/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.2%
2/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
FEBRILE INFECTION
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
KIDNEY INFECTION
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
LUNG ABSCESS
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
PERITONITIS BACTERIAL
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.8%
3/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.8%
3/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
PYELONEPHRITIS ACUTE
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
TUBERCULOSIS
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
FALL
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
HUMERUS FRACTURE
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
INCISIONAL HERNIA
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
WOUND DEHISCENCE
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.8%
3/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 INADEQUATE CONTROL
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ALCOHOLIC PSYCHOSIS
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
URINARY RETENTION
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
MEDIASTINAL HAEMATOMA
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.9%
5/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.2%
2/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
TACHYPNOEA
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ILEOCOLOSTOMY
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
AXILLARY VEIN THROMBOSIS
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CIRCULATORY COLLAPSE
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
EMBOLISM
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.2%
2/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
INTERMITTENT CLAUDICATION
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 ARTERIAL OCCLUSIVE DISEASE
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
THROMBOPHLEBITIS
|
0.00%
0/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.59%
1/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 FOLFOX-4
n=170 participants at risk
Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
FOLFOX-4 Alone
n=168 participants at risk
5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
25.9%
44/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
24.4%
41/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
28.8%
49/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
25.6%
43/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
45.3%
77/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
50.0%
84/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
26.5%
45/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
41.1%
69/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Ear and labyrinth disorders
VERTIGO
|
5.3%
9/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
7/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
13.5%
23/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.8%
8/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
17.6%
30/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
17.3%
29/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
18.8%
32/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
9.5%
16/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
47.6%
81/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
40.5%
68/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
5.3%
9/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.4%
9/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
40.6%
69/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
38.7%
65/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
19.4%
33/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
11.3%
19/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
28.2%
48/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
22.0%
37/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
18.8%
32/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
18.5%
31/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
31.8%
54/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
25.6%
43/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
12.9%
22/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.8%
8/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
22.9%
39/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
17.9%
30/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
7.6%
13/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
11.8%
20/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
15.3%
26/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
11.3%
19/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
20.0%
34/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
13.7%
23/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
5.9%
10/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
6.5%
11/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.0%
5/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
9.4%
16/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.2%
2/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.9%
10/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.8%
8/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
6.5%
11/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.8%
3/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
6.5%
11/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.8%
8/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
NEUROPATHY
|
5.9%
10/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
9.5%
16/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
NEUROTOXICITY
|
7.1%
12/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
7/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
PARAESTHESIA
|
11.2%
19/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
22.6%
38/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
27.1%
46/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
30.4%
51/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
POLYNEUROPATHY
|
5.3%
9/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.0%
5/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Psychiatric disorders
INSOMNIA
|
5.3%
9/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.6%
6/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
5.9%
10/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
7/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
8.8%
15/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
6.5%
11/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
5.9%
10/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
12.4%
21/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
10.1%
17/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
22.4%
38/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.60%
1/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
16.5%
28/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.8%
3/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
7.1%
12/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
NAIL DISORDER
|
6.5%
11/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.2%
2/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
11.2%
19/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
7/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
8.8%
15/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.6%
6/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
52.9%
90/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.4%
4/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
10.0%
17/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
7.6%
13/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
6.5%
11/170 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.8%
8/168 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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: GT60