Trial Outcomes & Findings for Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL) (NCT NCT00154102)
NCT ID: NCT00154102
Last Updated: 2017-01-30
Results Overview
Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1221 participants
Primary outcome timeframe
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Results posted on
2017-01-30
Participant Flow
First/Last subject in: 10 Aug 2004/4 Nov 2005. Clinical cut-off efficacy analyses except survival: 27 Jul 2006, Cut off date IRC data: 14 Dec 2006; cut-off safety analyses: 30 Nov 2007; cut-off survival analyses: 31 May 2009; cut-off KRAS analyses: 28 Aug 2009. 1221 subjects were randomised or treated, of whom 1198 were randomised and treated.
At the prescreening visit the subject completed the first informed consent form, and a sample of tumor tissue for determination of EGFR expression was to be obtained. The screening (baseline) visit was performed no more than 21 days before randomization. EGFR-expressing subjects completed a second informed consent form to participate in the study.
Participant milestones
| Measure |
Cetuximab Plus FOLFIRI
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Overall Study
STARTED
|
599
|
599
|
|
Overall Study
COMPLETED
|
592
|
597
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
Cetuximab Plus FOLFIRI
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Overall Study
investigational study phase ongoing
|
7
|
2
|
Baseline Characteristics
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
Baseline characteristics by cohort
| Measure |
Cetuximab Plus FOLFIRI
n=599 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=599 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
Total
n=1198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 10.52 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 11.06 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 10.79 • n=5 Participants
|
|
Age, Customized
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
374 participants
n=5 Participants
|
377 participants
n=7 Participants
|
751 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
224 participants
n=5 Participants
|
222 participants
n=7 Participants
|
446 participants
n=5 Participants
|
|
Gender
Female
|
230 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
473 Participants
n=5 Participants
|
|
Gender
Male
|
369 Participants
n=5 Participants
|
356 Participants
n=7 Participants
|
725 Participants
n=5 Participants
|
|
Region of Enrollment
Western Europe
|
262 participants
n=5 Participants
|
267 participants
n=7 Participants
|
529 participants
n=5 Participants
|
|
Region of Enrollment
Eastern Europe
|
203 participants
n=5 Participants
|
201 participants
n=7 Participants
|
404 participants
n=5 Participants
|
|
Region of Enrollment
Rest of the World
|
134 participants
n=5 Participants
|
131 participants
n=7 Participants
|
265 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006Population: Primary analysis on 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).
Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=599 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=599 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments
|
8.9 months
Interval 8.0 to 9.4
|
8.0 months
Interval 7.6 to 9.0
|
PRIMARY outcome
Timeframe: Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006Population: Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009
Duration from randomization until radiological progression (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 |
Cetuximab Plus FOLFIRI
n=316 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=350 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments
|
9.9 months
Interval 9.0 to 11.3
|
8.4 months
Interval 7.4 to 9.2
|
PRIMARY outcome
Timeframe: Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006Population: Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009
Duration from randomization until radiological progression (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 |
Cetuximab Plus FOLFIRI
n=214 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=183 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
|
7.4 months
Interval 6.1 to 8.0
|
7.7 months
Interval 7.3 to 9.2
|
SECONDARY outcome
Timeframe: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009Population: ITT population (allocation to treatment groups as randomized and treated)
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, whichever is later.
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=599 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=599 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Overall Survival Time (OS)
|
19.9 months
Interval 18.5 to 21.3
|
18.6 months
Interval 16.7 to 19.8
|
SECONDARY outcome
Timeframe: Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009Population: Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009
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, whichever is later.
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=316 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=350 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Overall Survival Time (KRAS Wild-Type Population)
|
23.5 months
Interval 21.2 to 26.3
|
20.0 months
Interval 17.4 to 21.7
|
SECONDARY outcome
Timeframe: Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009Population: Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009
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, whichever is later.
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=214 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=183 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Overall Survival Time (KRAS Mutant Population)
|
16.2 months
Interval 14.9 to 17.9
|
16.7 months
Interval 14.9 to 19.4
|
SECONDARY outcome
Timeframe: evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006Population: ITT population (allocation to treatment groups as randomized and treated)
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).
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=599 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=599 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Best Overall Response Rate - Independent Review Committee (IRC) Assessments
|
46.9 percentage of participants
Interval 42.9 to 51.0
|
38.7 percentage of participants
Interval 34.8 to 42.8
|
SECONDARY outcome
Timeframe: evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006Population: Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009
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).
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=316 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=350 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments
|
57.3 percentage participants
Interval 51.6 to 62.8
|
39.7 percentage participants
Interval 34.6 to 45.1
|
SECONDARY outcome
Timeframe: evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006Population: Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009
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).
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=214 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=183 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
|
31.3 percentage of participants
Interval 25.2 to 38.0
|
36.1 percentage of participants
Interval 29.1 to 43.5
|
SECONDARY outcome
Timeframe: Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006Population: ITT population (allocation to treatment groups as randomized and treated)
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 (based on modified WHO criteria).
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=599 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=599 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Disease Control Rate - Independent Review Committee (IRC) Assessments
|
84.3 percentage of participants
Interval 81.1 to 87.1
|
85.5 percentage of participants
Interval 82.4 to 88.2
|
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, 10 Aug 2004, until cut-off date, 27 July 2006Population: ITT population (allocation to treatment groups as randomized and treated)
Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment). Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=599 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=599 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Duration of Response - Independent Review Committee (IRC) Assessments
|
9.6 months
Interval 9.1 to 12.9
|
7.7 months
Interval 6.7 to 8.3
|
SECONDARY outcome
Timeframe: time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007Population: ITT population (allocation to treatment groups as randomized and treated)
Participants with no residual tumor after on-study surgery for metastases
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=599 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=599 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Participants With No Residual Tumor After Metastatic Surgery
|
29 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006Population: 1125 subjects (566 Cetuximab + FOLFIRI; 559 FOLFIRI alone) completed at least 1 evaluable questionnaire \& were included in the Evaluable for QLQ-C30 population. Numbers at each timepoint were (Cetuximab + FOLFORI/FOLFORI alone, respectively): baseline 430/423; Week 8 421/390; Week 16 312/309; Week 24 255/244; Week 32 164/154; Week 40 122/96
Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=566 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=559 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
At baseline
|
58.88 scores on a scale
Standard Error 1.185
|
60.33 scores on a scale
Standard Error 1.155
|
|
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
At week 8
|
59.02 scores on a scale
Standard Error 1.187
|
61.83 scores on a scale
Standard Error 1.176
|
|
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
At week 16
|
60.77 scores on a scale
Standard Error 1.276
|
63.29 scores on a scale
Standard Error 1.249
|
|
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
At week 24
|
61.83 scores on a scale
Standard Error 1.368
|
64.06 scores on a scale
Standard Error 1.364
|
|
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
At week 32
|
59.68 scores on a scale
Standard Error 1.590
|
65.07 scores on a scale
Standard Error 1.612
|
|
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
At week 40
|
63.43 scores on a scale
Standard Error 1.835
|
64.02 scores on a scale
Standard Error 1.991
|
SECONDARY outcome
Timeframe: at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006Population: 1125 subjects (566 in the Cetuximab + FOLFIRI arm and 559 in the FOLFIRI alone arm) completed at least one evaluable QLQ-C30 questionnaire and were thus included in the Evaluable for QLQ-C30 population
Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=566 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=559 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
At baseline
|
75.21 scores on a scale
Standard Error 1.426
|
77.28 scores on a scale
Standard Error 1.395
|
|
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
At week 8
|
74.14 scores on a scale
Standard Error 1.430
|
76.71 scores on a scale
Standard Error 1.415
|
|
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
At week 16
|
73.72 scores on a scale
Standard Error 1.533
|
76.67 scores on a scale
Standard Error 1.498
|
|
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
At week 24
|
76.31 scores on a scale
Standard Error 1.644
|
77.98 scores on a scale
Standard Error 1.633
|
|
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
At week 32
|
74.04 scores on a scale
Standard Error 1.903
|
75.64 scores on a scale
Standard Error 1.933
|
|
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
At week 40
|
76.58 scores on a scale
Standard Error 2.198
|
78.07 scores on a scale
Standard Error 2.388
|
SECONDARY outcome
Timeframe: time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007Population: Safety Population
Please refer to Adverse Events section for further details
Outcome measures
| Measure |
Cetuximab Plus FOLFIRI
n=600 Participants
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
FOLFIRI Alone
n=602 Participants
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
|
|---|---|---|
|
Safety - Number of Patients Experiencing Any Adverse Event
|
599 participants
|
597 participants
|
Adverse Events
Cetuximab Plus FOLFIRI
Serious events: 263 serious events
Other events: 593 other events
Deaths: 0 deaths
FOLFIRI Alone
Serious events: 204 serious events
Other events: 591 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab Plus FOLFIRI
n=600 participants at risk
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops.
Safety population: includes all treated subjects.
|
FOLFIRI Alone
n=602 participants at risk
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops.
Safety population: includes all treated subjects
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.3%
8/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.7%
16/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.2%
13/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.0%
6/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.2%
7/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
6.2%
37/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.8%
35/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
PLATELET TOXICITY
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
ARRHYTHMIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
ARRHYTHMIA SUPRAVENTRICULAR
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ARTERIOSPASM CORONARY
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 CONGESTIVE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CONDUCTION DISORDER
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
PALPITATIONS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
RIGHT VENTRICULAR FAILURE
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Cardiac disorders
TACHYCARDIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Endocrine disorders
DIABETES INSIPIDUS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 HERNIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.3%
14/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.2%
13/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ACUTE ABDOMEN
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.50%
3/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
COLONIC OBSTRUCTION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.0%
6/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
6.0%
36/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.5%
21/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ENTEROCOLITIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ENTEROVESICAL FISTULA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
GASTRO-INTESTINAL FISTULA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 HYPOMOTILITY
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 OBSTRUCTION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
HAEMATOCHEZIA
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.7%
10/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.2%
7/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
INGUINAL HERNIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 HAEMORRHAGE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.2%
7/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.3%
8/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
MESENTERIC VEIN THROMBOSIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
NAUSEA
|
1.3%
8/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.83%
5/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
PERITONEAL EFFUSION
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
PROCTALGIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.66%
4/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
SMALL INTESTINAL OBSTRUCTION
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.3%
8/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
VOMITING
|
2.5%
15/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.7%
16/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.0%
6/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.83%
5/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CATHETER RELATED COMPLICATION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CATHETER SITE HAEMATOMA
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CATHETER SITE INFLAMMATION
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CATHETER SITE PAIN
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
CHILLS
|
0.83%
5/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
DEATH
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
DISEASE PROGRESSION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
EXTRAVASATION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.3%
8/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.67%
4/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
INFLAMMATION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
INFLUENZA LIKE ILLNESS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
INFUSION SITE EXTRAVASATION
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
INFUSION SITE PAIN
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
LOCALISED OEDEMA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
4.3%
26/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.5%
21/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 STENOSIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
BILIARY FISTULA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CHOLECYSTITIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CHOLECYSTITIS ACUTE
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
DILATATION INTRAHEPATIC DUCT ACQUIRED
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.67%
4/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ABDOMINAL ABSCESS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ABDOMINAL INFECTION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 INTESTINAL
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
APPENDICITIS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.3%
8/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
CATHETER SEPSIS
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 SITE INFECTION
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
CELLULITIS
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.7%
10/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.66%
4/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
ERYSIPELAS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ESCHERICHIA BACTERAEMIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ESCHERICHIA SEPSIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
GASTROENTERITIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
HERPES ZOSTER
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
INFECTION
|
0.67%
4/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
LISTERIOSIS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.50%
3/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
NEUTROPENIC INFECTION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
OTITIS MEDIA CHRONIC
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
PELVIC ABSCESS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
PERIANAL ABSCESS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
1.5%
9/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.2%
7/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 KLEBSIELLA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
POSTOPERATIVE INFECTION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
RETROPERITONEAL ABSCESS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.67%
4/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
SINUSITIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
SKIN INFECTION
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
STREPTOCOCCAL SEPSIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
UPPER RESPIRATORY TRACT INFECTION
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.67%
4/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.50%
3/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
VARICELLA
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
WOUND INFECTION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ALCOHOL POISONING
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ANASTOMOTIC STENOSIS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
FIBULA FRACTURE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
FRACTURED SACRUM
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
INTESTINAL STOMA COMPLICATION
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
LIMB INJURY
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
PATELLA FRACTURE
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL BILE LEAK
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
SPINAL COMPRESSION FRACTURE
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
STENT OCCLUSION
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
SUBDURAL HAEMATOMA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
VASCULAR ACCESS COMPLICATION
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
HEPATIC ENZYME INCREASED
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
LABORATORY TEST ABNORMAL
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
URINE ANALYSIS ABNORMAL
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
WEIGHT DECREASED
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.67%
4/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.66%
4/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.7%
16/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.0%
12/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
DIABETIC KETOACIDOSIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ELECTROLYTE IMBALANCE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.67%
4/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
2.2%
13/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
LACTIC ACIDOSIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ORAL INTAKE REDUCED
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
JOINT SWELLING
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR ASSOCIATED FEVER
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER NEOPLASM
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN LOW MALIGNANT POTENTIAL TUMOUR
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
COMA
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
CONVULSION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
COORDINATION ABNORMAL
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
HEADACHE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
HEMIPARESIS
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
LETHARGY
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
LOSS OF CONSCIOUSNESS
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
SOMNOLENCE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
VOCAL CORD PARALYSIS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 CARDIO-VASCULAR INSUFFICIENCY
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ACUTE GASTROENTERITIS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ACUTE PNEUMONIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CIRCULATORY INSUFFICIENCY
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 OF OSTEOSYNTHESIS IN RIGHT ANCLE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
THROMBUS//CLOT IN VEIN OF LEFT HAND CAUSING INFECTION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ABNORMAL BEHAVIOUR
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
EUPHORIC MOOD
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CALCULUS URETERIC
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CALCULUS URINARY
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
DYSURIA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
HAEMORRHAGE URINARY TRACT
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
HYDRONEPHROSIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
NEPHROLITHIASIS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
URETERIC OBSTRUCTION
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
VAGINAL HAEMORRHAGE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
ASTHMA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
BRONCHOSPASM
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.2%
7/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.66%
4/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.50%
3/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
PLEURITIC PAIN
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
3.3%
20/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.7%
10/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
CATARACT OPERATION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.5%
9/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.83%
5/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
HYPERTENSION
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.83%
5/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.50%
3/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
ISCHAEMIA
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 OCCLUSIVE DISEASE
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
SUBCLAVIAN VEIN THROMBOSIS
|
0.00%
0/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
THROMBOSIS
|
0.67%
4/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.66%
4/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
VENA CAVA THROMBOSIS
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
0.33%
2/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 LIMB
|
0.17%
1/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing 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%
0/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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 FOLFIRI
n=600 participants at risk
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops.
Safety population: includes all treated subjects.
|
FOLFIRI Alone
n=602 participants at risk
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops.
Safety population: includes all treated subjects
|
|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
45.3%
272/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
41.4%
249/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
21.2%
127/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
19.9%
120/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
20.2%
121/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
21.1%
127/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
5.2%
31/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.3%
20/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
4.8%
29/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.8%
35/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
14.7%
88/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.2%
13/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
62.8%
377/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
58.6%
353/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
NAUSEA
|
53.7%
322/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
59.6%
359/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
32.3%
194/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
38.4%
231/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
28.2%
169/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
18.3%
110/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
23.7%
142/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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%
154/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
22.5%
135/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
19.8%
119/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
13.0%
78/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
7.6%
46/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
7.5%
45/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.5%
33/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
32.0%
192/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
30.9%
186/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
22.7%
136/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
10.6%
64/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
18.3%
110/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
18.6%
112/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
13.7%
82/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
8.8%
53/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
OEDEMA PERIPHERAL
|
8.0%
48/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
7.0%
42/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
General disorders
INJECTION SITE REACTION
|
6.7%
40/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
6.3%
38/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
17.8%
107/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.50%
3/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.0%
30/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.8%
35/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
15.7%
94/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
8.6%
52/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
28.2%
169/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
24.8%
149/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
9.7%
58/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.0%
30/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
7.0%
42/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.50%
3/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
6.3%
38/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
9.1%
55/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.0%
30/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.8%
23/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
10.7%
64/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
9.1%
55/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
7.2%
43/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
6.6%
40/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Nervous system disorders
DYSGEUSIA
|
6.8%
41/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
7.5%
45/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
9.5%
57/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
8.8%
53/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
10.7%
64/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
9.8%
59/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
8.8%
53/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.3%
32/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
8.3%
50/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.5%
27/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
RASH
|
45.0%
270/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.8%
23/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
37.3%
224/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
38.0%
229/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
24.3%
146/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.33%
2/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
22.2%
133/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
5.0%
30/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
16.8%
101/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.5%
27/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
16.2%
97/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
1.7%
10/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
12.2%
73/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
4.7%
28/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
11.5%
69/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
9.0%
54/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.83%
5/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
6.7%
40/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
2.0%
12/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
5.8%
35/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.50%
3/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Skin and subcutaneous tissue disorders
SKIN TOXICITY
|
5.7%
34/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
0.17%
1/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
HYPERTENSION
|
7.7%
46/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
6.0%
36/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
|
Vascular disorders
PHLEBITIS
|
6.3%
38/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.3%
20/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first 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
|
5.3%
32/600 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
3.3%
20/602 • Time from first dose up to 30 days after the last dose of study treatment.
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER