Trial Outcomes & Findings for PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study (NCT NCT00115765)
NCT ID: NCT00115765
Last Updated: 2018-10-17
Results Overview
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1053 participants
Primary outcome timeframe
Overall study
Results posted on
2018-10-17
Participant Flow
Participants were enrolled from 10 March 2005 through 19 October 2006.
Participant milestones
| Measure |
Irinotecan and Bevacizumab Without Panitumumab
Irinotecan-based chemotherapy and Bevacizumab Q2W alone
|
Oxaliplatin and Bevacizumab Plus Panitumumab
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
Irinotecan and Bevacizumab Plus Panitumumab
Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
115
|
413
|
410
|
115
|
|
Overall Study
COMPLETED
|
80
|
313
|
289
|
84
|
|
Overall Study
NOT COMPLETED
|
35
|
100
|
121
|
31
|
Reasons for withdrawal
| Measure |
Irinotecan and Bevacizumab Without Panitumumab
Irinotecan-based chemotherapy and Bevacizumab Q2W alone
|
Oxaliplatin and Bevacizumab Plus Panitumumab
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
Irinotecan and Bevacizumab Plus Panitumumab
Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
22
|
53
|
76
|
15
|
|
Overall Study
Physician Decision
|
4
|
15
|
18
|
13
|
|
Overall Study
Lost to Follow-up
|
3
|
20
|
18
|
1
|
|
Overall Study
Other
|
6
|
12
|
9
|
2
|
Baseline Characteristics
PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study
Baseline characteristics by cohort
| Measure |
Oxaliplatin and Bevacizumab Without Panitumumab
n=410 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
Irinotecan and Bevacizumab Plus Panitumumab
n=115 Participants
Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Irinotecan and Bevacizumab Without Panitumumab
n=115 Participants
Irinotecan-based chemotherapy and Bevacizumab Q2W alone
|
Oxaliplatin and Bevacizumab Plus Panitumumab
n=413 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Total
n=1053 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.0 Year
STANDARD_DEVIATION 11.9 • n=5 Participants
|
59.4 Year
STANDARD_DEVIATION 11.7 • n=7 Participants
|
57.8 Year
STANDARD_DEVIATION 12.0 • n=5 Participants
|
60.8 Year
STANDARD_DEVIATION 11.7 • n=4 Participants
|
60.4 Year
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
455 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
238 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
233 Participants
n=4 Participants
|
598 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
330 Participant
n=5 Participants
|
86 Participant
n=7 Participants
|
85 Participant
n=5 Participants
|
343 Participant
n=4 Participants
|
844 Participant
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
41 Participant
n=5 Participants
|
18 Participant
n=7 Participants
|
16 Participant
n=5 Participants
|
35 Participant
n=4 Participants
|
110 Participant
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
25 Participant
n=5 Participants
|
6 Participant
n=7 Participants
|
14 Participant
n=5 Participants
|
25 Participant
n=4 Participants
|
70 Participant
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participant
n=5 Participants
|
2 Participant
n=7 Participants
|
0 Participant
n=5 Participants
|
10 Participant
n=4 Participants
|
22 Participant
n=21 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
2 Participant
n=5 Participants
|
0 Participant
n=7 Participants
|
0 Participant
n=5 Participants
|
0 Participant
n=4 Participants
|
2 Participant
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participant
n=5 Participants
|
2 Participant
n=7 Participants
|
0 Participant
n=5 Participants
|
0 Participant
n=4 Participants
|
3 Participant
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participant
n=5 Participants
|
0 Participant
n=7 Participants
|
0 Participant
n=5 Participants
|
0 Participant
n=4 Participants
|
1 Participant
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participant
n=5 Participants
|
1 Participant
n=7 Participants
|
0 Participant
n=5 Participants
|
0 Participant
n=4 Participants
|
1 Participant
n=21 Participants
|
|
ECOG Score
0
|
239 Participant
n=5 Participants
|
68 Participant
n=7 Participants
|
74 Participant
n=5 Participants
|
253 Participant
n=4 Participants
|
634 Participant
n=21 Participants
|
|
ECOG Score
1
|
171 Participant
n=5 Participants
|
47 Participant
n=7 Participants
|
41 Participant
n=5 Participants
|
160 Participant
n=4 Participants
|
419 Participant
n=21 Participants
|
|
Number of Metastatic Organs
None
|
0 Participant
n=5 Participants
|
0 Participant
n=7 Participants
|
0 Participant
n=5 Participants
|
1 Participant
n=4 Participants
|
1 Participant
n=21 Participants
|
|
Number of Metastatic Organs
1
|
199 Participant
n=5 Participants
|
46 Participant
n=7 Participants
|
53 Participant
n=5 Participants
|
204 Participant
n=4 Participants
|
502 Participant
n=21 Participants
|
|
Number of Metastatic Organs
>1
|
211 Participant
n=5 Participants
|
69 Participant
n=7 Participants
|
62 Participant
n=5 Participants
|
208 Participant
n=4 Participants
|
550 Participant
n=21 Participants
|
|
Primary Site of Disease
Colon
|
326 Participant
n=5 Participants
|
92 Participant
n=7 Participants
|
95 Participant
n=5 Participants
|
322 Participant
n=4 Participants
|
835 Participant
n=21 Participants
|
|
Primary Site of Disease
Rectal
|
84 Participant
n=5 Participants
|
23 Participant
n=7 Participants
|
20 Participant
n=5 Participants
|
91 Participant
n=4 Participants
|
218 Participant
n=21 Participants
|
|
Prior adjuvant chemotherapy
Yes
|
77 Participant
n=5 Participants
|
38 Participant
n=7 Participants
|
36 Participant
n=5 Participants
|
80 Participant
n=4 Participants
|
231 Participant
n=21 Participants
|
|
Prior adjuvant chemotherapy
No
|
333 Participant
n=5 Participants
|
77 Participant
n=7 Participants
|
79 Participant
n=5 Participants
|
333 Participant
n=4 Participants
|
822 Participant
n=21 Participants
|
PRIMARY outcome
Timeframe: Overall studyPopulation: Intention-to-Treat
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=413 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=410 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Progression-Free Survival (Oxaliplatin)
|
10.0 Month
Interval 8.9 to 11.0
|
11.4 Month
Interval 10.5 to 11.9
|
PRIMARY outcome
Timeframe: Overall StudyPopulation: Intention-to-Treat
Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=115 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=115 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Objective Tumor Response Through Week 12 (Irinotecan)
|
29 Participant
|
27 Participant
|
SECONDARY outcome
Timeframe: Overall studyPopulation: Intention-to-Treat
Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=413 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=410 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Overall Survival (Oxaliplatin)
|
19.4 Month
Interval 18.4 to 20.8
|
24.5 Month
Interval 20.4 to 24.5
|
SECONDARY outcome
Timeframe: Overall studyPopulation: Intention-to-Treat
Best overall response of complete or partial response within oxaliplatin stratum
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=413 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=410 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Objective Tumor Response Rate (Oxaliplatin)
|
190 Participant
|
196 Participant
|
SECONDARY outcome
Timeframe: Overall StudyPopulation: Intention-to-Treat
Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the oxaliplatin stratum
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=413 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=410 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Time to Progression (Oxaliplatin)
|
10.8 Month
Interval 9.5 to 11.3
|
11.4 Month
Interval 10.9 to 12.2
|
SECONDARY outcome
Timeframe: Overall studyPopulation: Intention-to-Treat
Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the oxaliplatin stratum.
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=413 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=410 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Time to Treatment Failure (Oxaliplatin)
|
5.7 Month
Interval 5.5 to 6.0
|
5.9 Month
Interval 5.7 to 6.2
|
SECONDARY outcome
Timeframe: Overall studyPopulation: Intention-to-Treat
Incidence of mortality from any cause in groups treated with Irinotecan. Incidence is provided in lieu of the median time to death since the median or its measure of dispersion was not estimable for at least one treatment arm.
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=115 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=115 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Overall Survival (Irinotecan)
|
26 Participant
|
18 Participant
|
SECONDARY outcome
Timeframe: Overall StudyPopulation: Intention-to-Treat
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=115 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=115 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Progression-free Survival (Irinotecan)
|
10.1 Month
Interval 8.2 to 13.7
|
11.7 Month
Interval 9.0 to 13.2
|
SECONDARY outcome
Timeframe: Overall StudyPopulation: Intention-to-Treat
Best overall response of complete or partial response within irinotecan stratum
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=115 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=115 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Objective Tumor Response Rate (Irinotecan)
|
49 Participant
|
46 Participant
|
SECONDARY outcome
Timeframe: Overall StudyPopulation: Intention-to-Treat
Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the irinotecan stratum
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=115 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=115 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Time to Progression (Irinotecan)
|
11.1 Month
Interval 8.3 to 14.1
|
11.9 Month
Interval 9.0 to 13.2
|
SECONDARY outcome
Timeframe: Overall StudyPopulation: Intention-to-Treat
Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the irinotecan stratum
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=115 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=115 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Time to Treatment Failure (Irinotecan)
|
6.6 Month
Interval 5.9 to 8.0
|
6.0 Month
Interval 4.8 to 6.9
|
POST_HOC outcome
Timeframe: Overall StudyPopulation: Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with oxaliplatin
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS)
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=201 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=203 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Progression-free Survival (Wild-type KRAS)
|
9.8 Month
Interval 8.4 to 11.3
|
11.5 Month
Interval 10.6 to 12.3
|
POST_HOC outcome
Timeframe: Overall StudyPopulation: Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with oxaliplatin
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS)
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=135 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=125 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Progression-free Survival (Mutant KRAS)
|
10.4 Month
Interval 9.1 to 11.3
|
11.0 Month
Interval 9.9 to 12.8
|
POST_HOC outcome
Timeframe: Overall StudyPopulation: Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with oxaliplatin
Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=201 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=203 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Overall Survival (Wild-type KRAS)
|
71 Participant
|
46 Participant
|
POST_HOC outcome
Timeframe: Overall StudyPopulation: Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with oxaliplatin
Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median.
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=135 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=125 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Overall Survival (Mutant KRAS)
|
47 Participant
|
45 Participant
|
POST_HOC outcome
Timeframe: Overall StudyPopulation: Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with irinotecan
Best overall response of complete or partial response in participants treated with irinotecan and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS)
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=57 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=58 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Objective Tumor Response Rate (Wild-type KRAS)
|
31 Participant
|
28 Participant
|
POST_HOC outcome
Timeframe: Overall StudyPopulation: Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with irinotecan
Best overall response of complete or partial response in participants treated with irinotecan and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS)
Outcome measures
| Measure |
Oxaliplatin and Bevacizumab Plus Panitumumab
n=47 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
|
Oxaliplatin and Bevacizumab Without Panitumumab
n=39 Participants
Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
|
|---|---|---|
|
Objective Tumor Response Rate (Mutant KRAS)
|
14 Participant
|
15 Participant
|
Adverse Events
Panit. Plus Bevacizumab With Chemotherapy
Serious events: 306 serious events
Other events: 516 other events
Deaths: 0 deaths
Bevacizumab With Chemotherapy
Serious events: 188 serious events
Other events: 505 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panit. Plus Bevacizumab With Chemotherapy
n=518 participants at risk
|
Bevacizumab With Chemotherapy
n=510 participants at risk
|
|---|---|---|
|
Infections and infestations
CYSTITIS KLEBSIELLA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
GASTROENTERITIS
|
0.77%
4/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.59%
3/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
HERPES SIMPLEX
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
INFECTION
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
INTERTRIGO CANDIDA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
EXTRADURAL ABSCESS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
FUNGAEMIA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
FUNGAL INFECTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.78%
4/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
3.9%
20/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.8%
9/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
GRANULOCYTOPENIA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
HAEMOLYSIS
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.7%
9/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
8/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
SPLENIC INFARCTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
1.2%
6/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.98%
5/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.98%
5/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
ARRHYTHMIA
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
ARTERIOSPASM CORONARY
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.78%
4/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.78%
4/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
PALPITATIONS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
TACHYCARDIA
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
DIPLOPIA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
ECTROPION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
EYELID DISORDER
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
EYELID FUNCTION DISORDER
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
VISUAL DISTURBANCE
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ABDOMINAL ADHESIONS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.4%
23/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.3%
17/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ANO-RECTAL ULCER
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ASCITES
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
CAECITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
COLITIS
|
0.77%
4/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
COLONIC OBSTRUCTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.77%
4/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
DIARRHOEA
|
12.2%
63/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.9%
15/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
DIARRHOEA HAEMORRHAGIC
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
DUODENAL PERFORATION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
DUODENAL ULCER PERFORATION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
DUODENITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ENTERITIS
|
0.97%
5/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ENTEROCUTANEOUS FISTULA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ENTEROVESICAL FISTULA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
EROSIVE OESOPHAGITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
FAECALOMA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
GASTRIC ULCER PERFORATION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
GASTROINTESTINAL FISTULA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
1.4%
7/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.78%
4/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
GASTROINTESTINAL INFLAMMATION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
GASTROINTESTINAL OBSTRUCTION
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
GASTROINTESTINAL PERFORATION
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
GASTROINTESTINAL TOXICITY
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
GASTROINTESTINAL ULCER
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ILEUS
|
1.4%
7/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.59%
3/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
1.4%
7/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.98%
5/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.77%
4/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
LARGE INTESTINAL OBSTRUCTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
FUNGAL SEPSIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
MALLORY-WEISS SYNDROME
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
NAUSEA
|
4.6%
24/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.4%
7/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
PERITONITIS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
PNEUMOPERITONEUM
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMORRHAGE
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
2.3%
12/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
8/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
VOMITING
|
5.2%
27/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.0%
10/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
ASTHENIA
|
1.9%
10/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.78%
4/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
CATHETER RELATED COMPLICATION
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
CHEST PAIN
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
CHILLS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
FATIGUE
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
INFUSION RELATED REACTION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
MUCOSAL INFLAMMATION
|
1.2%
6/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.77%
4/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
PAIN
|
0.77%
4/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
PELVIC MASS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
PNEUMATOSIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
PYREXIA
|
3.1%
16/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.8%
9/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
SWELLING
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
ULCER
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
GALLBLADDER FISTULA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
HEPATIC LESION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
JAUNDICE CHOLESTATIC
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.77%
4/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
ABSCESS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
BACTERAEMIA
|
0.97%
5/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.78%
4/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.59%
3/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
CANDIDIASIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
CATHETER RELATED INFECTION
|
1.4%
7/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
CATHETER SEPSIS
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
CELLULITIS
|
0.77%
4/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
CELLULITIS GANGRENOUS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
CELLULITIS STAPHYLOCOCCAL
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
CLOSTRIDIAL INFECTION
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
KIDNEY INFECTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
MEDIASTINITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
MENINGITIS CRYPTOCOCCAL
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
MUSCLE ABSCESS
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
NECROTISING FASCIITIS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
NEUTROPENIC INFECTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
OSTEOMYELITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
PAROTITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
PELVIC ABSCESS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
PERITONEAL INFECTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
PNEUMONIA
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.8%
9/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
RASH PUSTULAR
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
RECTAL ABSCESS
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
RETROPERITONEAL ABSCESS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
SEPSIS
|
3.1%
16/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.6%
8/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.59%
3/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
STREPTOCOCCAL BACTERAEMIA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.4%
7/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
URINARY TRACT INFECTION FUNGAL
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
UROSEPSIS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
WOUND INFECTION
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC LEAK
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
CARBON MONOXIDE POISONING
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
DRUG TOXICITY
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL STOMA COMPLICATION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
IMPLANTABLE DEFIBRILLATOR MALFUNCTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
WOUND
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
BLOOD AMYLASE INCREASED
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
BLOOD MAGNESIUM DECREASED
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
ELECTROCARDIOGRAM ABNORMAL
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
HAEMOGLOBIN INCREASED
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
PROTHROMBIN TIME PROLONGED
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
WEIGHT DECREASED
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.97%
5/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
13.9%
72/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.1%
21/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
2.3%
12/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.78%
4/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
1.2%
6/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.97%
5/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.2%
6/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
SHOULDER PAIN
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
SOFT TISSUE NECROSIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
2.3%
12/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.78%
4/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER METASTATIC
|
1.7%
9/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLORECTAL CANCER
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLORECTAL CANCER METASTATIC
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT RECURRENT
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
APHASIA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
CONVULSION
|
0.97%
5/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
COORDINATION ABNORMAL
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
DIZZINESS
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.78%
4/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
HEADACHE
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.59%
3/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
HYPERTENSIVE ENCEPHALOPATHY
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
LETHARGY
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
NEUROPATHY
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
RADICULOPATHY
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
SYNCOPE
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.59%
3/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
DEPRESSION
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
PANIC ATTACK
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
DYSURIA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
FAECALURIA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.2%
6/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.78%
4/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
URETERIC OBSTRUCTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
URETHRAL OBSTRUCTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
VESICAL FISTULA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
FEMALE GENITAL TRACT FISTULA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
VULVAL DISORDER
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
DYSAESTHESIA PHARYNX
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.5%
8/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
12/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXACERBATED
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
PLATYPNOEA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
6.8%
35/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.3%
17/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
INTERTRIGO
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.97%
5/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
SKIN REACTION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
TELANGIECTASIA
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
COLECTOMY
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
CRYOTHERAPY
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
HEPATECTOMY
|
2.7%
14/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.2%
6/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
HEPATIC EMBOLISATION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
HIGH FREQUENCY ABLATION
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
LESION EXCISION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
LIVER OPERATION
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
LUNG NEOPLASM SURGERY
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
AXILLARY VEIN THROMBOSIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
3.3%
17/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
12/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
EMBOLISM
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
HAEMATOMA
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
HAEMORRHAGE
|
0.00%
0/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
HYPERTENSION
|
0.77%
4/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.98%
5/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
HYPOTENSION
|
0.77%
4/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.2%
6/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.20%
1/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.19%
1/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
SUBCLAVIAN VEIN THROMBOSIS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
THROMBOSIS
|
0.58%
3/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
VENA CAVA THROMBOSIS
|
0.39%
2/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Panit. Plus Bevacizumab With Chemotherapy
n=518 participants at risk
|
Bevacizumab With Chemotherapy
n=510 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
34.2%
177/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
28.8%
147/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
10.2%
53/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.8%
60/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
34.6%
179/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
40.6%
207/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
13.7%
71/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.2%
108/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
CONJUNCTIVITIS
|
6.0%
31/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.2%
6/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
LACRIMATION INCREASED
|
6.6%
34/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
34/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
VISION BLURRED
|
5.6%
29/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.3%
22/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
25.5%
132/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
22.4%
114/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
9.3%
48/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.5%
38/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
CONSTIPATION
|
41.9%
217/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
36.7%
187/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
DIARRHOEA
|
74.3%
385/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
68.6%
350/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
DRY MOUTH
|
5.8%
30/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.1%
31/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
16.6%
86/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.1%
72/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
6.0%
31/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.5%
18/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
FLATULENCE
|
6.4%
33/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.4%
48/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
6.8%
35/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.8%
40/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
7.9%
41/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.6%
49/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
NAUSEA
|
69.3%
359/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
72.2%
368/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
ORAL PAIN
|
8.9%
46/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.8%
40/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
PROCTALGIA
|
6.6%
34/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.7%
24/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
8.3%
43/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
34/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
STOMATITIS
|
33.0%
171/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
17.8%
91/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
VOMITING
|
41.5%
215/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
39.0%
199/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
ASTHENIA
|
17.8%
92/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
68/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
CHILLS
|
12.2%
63/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
10.8%
55/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
FATIGUE
|
68.3%
354/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
72.7%
371/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
MUCOSAL INFLAMMATION
|
30.7%
159/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.4%
104/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
OEDEMA PERIPHERAL
|
10.4%
54/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.0%
61/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
PAIN
|
7.3%
38/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.6%
39/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
PYREXIA
|
21.4%
111/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
16.1%
82/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
TEMPERATURE INTOLERANCE
|
12.5%
65/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
19.4%
99/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
PARONYCHIA
|
9.8%
51/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
SINUSITIS
|
5.0%
26/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.9%
35/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.0%
26/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.5%
38/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
13.9%
72/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.2%
47/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
4.8%
25/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.3%
32/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
WEIGHT DECREASED
|
32.0%
166/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.0%
107/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
40.7%
211/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
30.4%
155/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
9.7%
50/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
10.0%
51/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
24.9%
129/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.1%
72/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
8.3%
43/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
34/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
6.8%
35/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.8%
9/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
33.2%
172/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
73/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
28.6%
148/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.7%
14/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
5.0%
26/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.4%
12/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.6%
60/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.9%
71/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
13.7%
71/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.5%
74/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.8%
30/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.1%
31/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
5.6%
29/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.0%
46/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
10.4%
54/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.6%
49/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
SHOULDER PAIN
|
6.4%
33/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.8%
40/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
DIZZINESS
|
20.7%
107/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.2%
93/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
DYSGEUSIA
|
18.3%
95/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
19.0%
97/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
HEADACHE
|
18.3%
95/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
22.2%
113/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
HYPOAESTHESIA
|
6.4%
33/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.0%
41/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
NEUROPATHY
|
18.9%
98/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
22.5%
115/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
18.1%
94/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.8%
106/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
PARAESTHESIA
|
15.8%
82/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.4%
104/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
12.4%
64/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
16.7%
85/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
ANXIETY
|
11.8%
61/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
12.7%
65/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
DEPRESSION
|
17.6%
91/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
68/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
INSOMNIA
|
23.6%
122/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
24.7%
126/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
HAEMATURIA
|
5.6%
29/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.5%
23/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
PROTEINURIA
|
8.9%
46/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.0%
46/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
20.5%
106/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
19.0%
97/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
6.0%
31/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.1%
31/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
24.3%
126/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
19.6%
100/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
28.2%
146/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
32.2%
164/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
5.2%
27/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.5%
38/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
13.7%
71/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.2%
57/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
5.0%
26/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.9%
25/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
21.4%
111/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
16.9%
86/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
34.6%
179/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.4%
7/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
27.6%
143/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.5%
38/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
14.5%
75/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.7%
24/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
6.4%
33/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.39%
2/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
7.9%
41/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.3%
17/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
10.0%
52/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.1%
31/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
27.2%
141/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.5%
33/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
RASH
|
63.9%
331/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.9%
71/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
13.9%
72/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
2.0%
10/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
2.5%
13/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.1%
26/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
6.2%
32/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.98%
5/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
5.0%
26/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.9%
25/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
HYPERTENSION
|
16.6%
86/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.0%
107/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
HYPOTENSION
|
9.5%
49/518 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
4.7%
24/510 • First dose through maximum of safety FU or 30 days after last dose
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
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 after completion. 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 multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER