Trial Outcomes & Findings for SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial (NCT NCT00418938)
NCT ID: NCT00418938
Last Updated: 2018-10-17
Results Overview
Progression-free survival is defined as time from the date of randomization to the date of first progression per modified RECIST version 1.0 (based on central review of the radiographic scans), or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
266 participants
Primary outcome timeframe
From randomization up to 65 months.
Results posted on
2018-10-17
Participant Flow
We enrolled 266 subjects, but we only perform analyses on the Full Analysis Set, defined as all randomized subjects who provide informed consent before the initiation of any study specific procedures and who receive at least one dose of panitumumab or bevacizumab. There are 264 patients in this Full Analysis Set.
Participant milestones
| Measure |
Panitumumab Plus FOLFIRI
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
|
Bevacizumab Plus FOLFIRI
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
131
|
|
Overall Study
COMPLETED
|
109
|
108
|
|
Overall Study
NOT COMPLETED
|
24
|
23
|
Reasons for withdrawal
| Measure |
Panitumumab Plus FOLFIRI
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
|
Bevacizumab Plus FOLFIRI
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
|
|---|---|---|
|
Overall Study
Reimbursement
|
1
|
0
|
|
Overall Study
Administrative decision
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
16
|
15
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
On-going
|
1
|
1
|
|
Overall Study
Ineligibility Determined
|
1
|
0
|
Baseline Characteristics
SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial
Baseline characteristics by cohort
| Measure |
Panitumumab Plus FOLFIRI
n=133 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
|
Bevacizumab Plus FOLFIRI
n=131 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
102 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (Fully active)
|
74 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 (Restricted in physically strenuous activity)
|
58 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary tumor diagnosis
Colon
|
102 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Primary tumor diagnosis
Rectum
|
31 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Number of metastatic organs
1
|
49 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Number of metastatic organs
2
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Number of metastatic organs
>=3
|
44 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Number of metastatic organs
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization up to 65 months.Population: Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.
Progression-free survival is defined as time from the date of randomization to the date of first progression per modified RECIST version 1.0 (based on central review of the radiographic scans), or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later).
Outcome measures
| Measure |
Panitumumab Plus FOLFIRI
n=127 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
|
Bevacizumab Plus FOLFIRI
n=123 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
|
|---|---|---|
|
Progression-free Survival (PFS)
Wild-type KRAS (n=91,91)
|
7.7 months
Interval 5.7 to 11.8
|
9.2 months
Interval 7.8 to 10.6
|
|
Progression-free Survival (PFS)
Mutant KRAS (n=36,32)
|
3.7 months
Interval 2.7 to 5.5
|
6.4 months
Interval 3.5 to 17.1
|
SECONDARY outcome
Timeframe: From randomization up to 65 months.Population: Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.
Overall survival is defined as time from the date of randomization to the date of death due to any cause. Subjects who have not died or are lost to follow-up at the analysis cutoff date will be censored at their last contact date.
Outcome measures
| Measure |
Panitumumab Plus FOLFIRI
n=127 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
|
Bevacizumab Plus FOLFIRI
n=123 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
|
|---|---|---|
|
Overall Survival
Wild-type KRAS (n=91,91)
|
18.0 months
Interval 13.5 to 21.7
|
21.4 months
Interval 16.5 to 24.6
|
|
Overall Survival
Mutant KRAS (n=36,32)
|
8.7 months
Interval 6.1 to 14.5
|
13.5 months
Interval 9.1 to 14.3
|
SECONDARY outcome
Timeframe: From randomization up to 65 months.Population: Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.
Objective response rate is defined as incidence of either a confirmed complete response (CR) or partial response (PR) on study up to starting a new anti-tumor therapy and will be based on modified RECIST version 1.0 (responder) by central assessment.
Outcome measures
| Measure |
Panitumumab Plus FOLFIRI
n=121 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
|
Bevacizumab Plus FOLFIRI
n=113 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
|
|---|---|---|
|
Objective Response Rate
Wild-type KRAS (n=91,91)
|
32.18 % of patients
Interval 22.56 to 43.06
|
19.28 % of patients
Interval 11.44 to 29.41
|
|
Objective Response Rate
Mutant KRAS (n=36,32)
|
11.76 % of patients
Interval 3.3 to 27.45
|
3.33 % of patients
Interval 0.08 to 17.22
|
SECONDARY outcome
Timeframe: From randomization up to 65 months.Population: Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.
Time to response is defined as time from the date of randomization to the date of first confirmed objective response
Outcome measures
| Measure |
Panitumumab Plus FOLFIRI
n=121 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
|
Bevacizumab Plus FOLFIRI
n=113 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
|
|---|---|---|
|
Time to Response
Wild-type KRAS (n=91,91)
|
2.1 months
Inter-Quartile Range 2.2 • Interval 1.8 to 3.9
|
3.7 months
Inter-Quartile Range 1.2 • Interval 2.0 to 4.0
|
|
Time to Response
Mutant KRAS (n=36,32)
|
2.2 months
Inter-Quartile Range 0.2 • Interval 2.0 to 2.3
|
1.8 months
Inter-Quartile Range NA • Interval 1.8 to 1.8
|
SECONDARY outcome
Timeframe: From randomization up to 65 months.Population: Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.
Time to progression is defined as time from the date of randomization to the date of radiographic disease progression per modified RECIST version 1.0 (per central assessment).
Outcome measures
| Measure |
Panitumumab Plus FOLFIRI
n=127 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
|
Bevacizumab Plus FOLFIRI
n=123 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
|
|---|---|---|
|
Time to Progression
Wild-type KRAS
|
11.1 months
Interval 7.5 to 13.2
|
9.4 months
Interval 8.2 to 11.9
|
|
Time to Progression
Mutant KRAS
|
4.5 months
Interval 3.0 to 12.0
|
7.4 months
Interval 5.7 to 19.2
|
SECONDARY outcome
Timeframe: From randomization up to 65 months.Population: Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.
Disease control is defined as incidence of objective response or stable disease on study up to starting a new anti-tumor therapy.
Outcome measures
| Measure |
Panitumumab Plus FOLFIRI
n=121 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
|
Bevacizumab Plus FOLFIRI
n=113 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
|
|---|---|---|
|
Disease Control
Wild-type KRAS (n=91,91)
|
72.41 % of participants
Interval 61.79 to 81.46
|
79.52 % of participants
Interval 69.24 to 87.59
|
|
Disease Control
Mutant KRAS (n=36,32)
|
52.94 % of participants
Interval 35.13 to 70.22
|
66.67 % of participants
Interval 47.19 to 82.71
|
SECONDARY outcome
Timeframe: From randomization up to 65 months.Population: Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.
Duration of response is defined as time from first confirmed objective response to disease progression per modified RECIST version 1.0 (by central assessment).
Outcome measures
| Measure |
Panitumumab Plus FOLFIRI
n=121 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
|
Bevacizumab Plus FOLFIRI
n=113 Participants
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
|
|---|---|---|
|
Duration of Response
Wild-type KRAS (n=91,91)
|
12.7 months
Interval 7.9 to 19.1
|
8.9 months
Interval 6.5 to 13.6
|
|
Duration of Response
Mutant KRAS (n=36,32)
|
10.2 months
Interval 9.8 to 13.5
|
15.2 months
Only 1 event of response in this category.
|
Adverse Events
Panitumumab Plus FOLFIRI
Serious events: 61 serious events
Other events: 133 other events
Deaths: 0 deaths
Bevacizumab Plus FOLFIRI
Serious events: 39 serious events
Other events: 129 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panitumumab Plus FOLFIRI
n=133 participants at risk
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
|
Bevacizumab Plus FOLFIRI
n=131 participants at risk
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
2.3%
3/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Cardiac disorders
Atrial fibrillation
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Cardiac disorders
Cardiomyopathy
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Cardiac disorders
Tachycardia
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
4/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
3.1%
4/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Constipation
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
9/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
3.1%
4/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Enteritis
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Ileus
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Melaena
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
2.3%
3/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.0%
4/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
2.3%
3/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
5/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
2.3%
3/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Asthenia
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Chest pain
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Device occlusion
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Fatigue
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Mucosal inflammation
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Non-cardiac chest pain
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Oedema
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Pain
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Pyrexia
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Stent malfunction
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Bone abscess
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Device related infection
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Gastroenteritis
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Neutropenic sepsis
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Pneumonia
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Sepsis
|
2.3%
3/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Septic shock
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Urinary tract infection
|
2.3%
3/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
2.3%
3/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Fall
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Heart injury
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Investigations
Weight decreased
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
7/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
4.6%
6/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Nervous system disorders
Syncope
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Psychiatric disorders
Confusional state
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Renal and urinary disorders
Renal failure acute
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.75%
1/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.0%
8/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Vascular disorders
Deep vein thrombosis
|
2.3%
3/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Vascular disorders
Hypotension
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
Other adverse events
| Measure |
Panitumumab Plus FOLFIRI
n=133 participants at risk
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
|
Bevacizumab Plus FOLFIRI
n=131 participants at risk
subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.1%
28/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
22.9%
30/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
11/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
10.7%
14/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.1%
44/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
40.5%
53/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.5%
14/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
14.5%
19/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Eye disorders
Conjunctivitis
|
8.3%
11/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
2.3%
3/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Eye disorders
Lacrimation increased
|
7.5%
10/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
4.6%
6/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.3%
23/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
28.2%
37/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
11/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
3.1%
4/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Constipation
|
32.3%
43/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
26.0%
34/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
69.9%
93/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
66.4%
87/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.8%
13/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
9.2%
12/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
7/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
6.1%
8/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.0%
8/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
6.9%
9/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
51.9%
69/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
67.2%
88/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Stomatitis
|
30.8%
41/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
25.2%
33/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
35.3%
47/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
35.9%
47/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Asthenia
|
6.8%
9/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
13.7%
18/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Chills
|
6.8%
9/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
5.3%
7/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Fatigue
|
57.1%
76/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
61.1%
80/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Mucosal inflammation
|
26.3%
35/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
22.9%
30/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Oedema peripheral
|
12.8%
17/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
7.6%
10/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Pain
|
7.5%
10/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
5.3%
7/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
General disorders
Pyrexia
|
15.8%
21/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
9.9%
13/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Paronychia
|
10.5%
14/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.00%
0/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.3%
15/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
11.5%
15/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Infections and infestations
Urinary tract infection
|
9.0%
12/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
11.5%
15/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Investigations
International normalised ratio increased
|
5.3%
7/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Investigations
Weight decreased
|
19.5%
26/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
26.7%
35/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Investigations
Weight increased
|
5.3%
7/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.6%
38/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
31.3%
41/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Dehydration
|
21.1%
28/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
19.1%
25/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
11/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
4.6%
6/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.0%
8/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
3.8%
5/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
31.6%
42/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
17.6%
23/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
35.3%
47/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
10.7%
14/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
7/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
8.4%
11/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.3%
15/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
11.5%
15/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.3%
3/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
9.2%
12/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.5%
6/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
6.1%
8/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.8%
13/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
5.3%
7/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Nervous system disorders
Dizziness
|
12.8%
17/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
9.2%
12/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Nervous system disorders
Dysgeusia
|
4.5%
6/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
6.9%
9/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Nervous system disorders
Headache
|
8.3%
11/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
9.2%
12/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.3%
11/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
14.5%
19/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Psychiatric disorders
Anxiety
|
9.0%
12/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
6.1%
8/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Psychiatric disorders
Depression
|
8.3%
11/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
6.9%
9/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Psychiatric disorders
Insomnia
|
15.0%
20/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
16.0%
21/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
7.6%
10/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.3%
15/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
9.9%
13/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.0%
20/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
13.0%
17/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.0%
12/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
22.1%
29/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.0%
4/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
8.4%
11/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.8%
9/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
7.6%
10/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.8%
5/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
5.3%
7/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.0%
24/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
21.4%
28/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
27.1%
36/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
3.1%
4/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.5%
18/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
6.1%
8/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.8%
5/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
6.9%
9/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
9.8%
13/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.3%
7/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
4.6%
6/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.0%
16/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
5.3%
7/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
60.2%
80/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
6.9%
9/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
12.0%
16/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
1.5%
2/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Vascular disorders
Deep vein thrombosis
|
6.0%
8/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
0.76%
1/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Vascular disorders
Hypertension
|
1.5%
2/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
8.4%
11/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
|
Vascular disorders
Hypotension
|
14.3%
19/133 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
6.9%
9/131 • The median reporting period was since randomization date to 65 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER