Trial Outcomes & Findings for Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair (NCT NCT02912559)
NCT ID: NCT02912559
Last Updated: 2026-05-05
Results Overview
DFS will be compared between treatment arms using the stratified log rank test at one-sided level 0.025. If zero DFS events are observed in a certain stratum at an interim analysis and unstratified log-rank is used, all subsequent analyses for DFS will use unstratified log-rank test. The hazard ratio (HR) for DFS will be estimated using a stratified Cox proportional hazards model and the 95 percent confidence interval (CI) for the HR will be provided. Results from an unstratified analysis will also be provided. Kaplan-Meier methodology will be used to estimate the median DFS for each treatment arm, and Kaplan-Meier curves will be produced. Brookmeyer Crowley methodology will be used to construct the 95 percent CI for the median DFS for each treatment arm.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
712 participants
Primary outcome timeframe
3 years
Results posted on
2026-05-05
Participant Flow
Participant milestones
| Measure |
Arm II (Combination Chemotherapy)
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\>
\> Biospecimen Collection: Undergo blood sample collection\>
\> Computed Tomography: Undergo CT\>
\> Fluorouracil: Given IV\>
\> Leucovorin Calcium: Given IV\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Oxaliplatin: Given IV\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm I (Combination Chemotherapy, Atezolizumab)
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Atezolizumab: Given IV\>
\> Biospecimen Collection: Undergo blood sample collection\>
\> Computed Tomography: Undergo CT\>
\> Fluorouracil: Given IV\>
\> Leucovorin Calcium: Given IV\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Oxaliplatin: Given IV\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
357
|
355
|
|
Overall Study
COMPLETED
|
214
|
163
|
|
Overall Study
NOT COMPLETED
|
143
|
192
|
Reasons for withdrawal
| Measure |
Arm II (Combination Chemotherapy)
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\>
\> Biospecimen Collection: Undergo blood sample collection\>
\> Computed Tomography: Undergo CT\>
\> Fluorouracil: Given IV\>
\> Leucovorin Calcium: Given IV\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Oxaliplatin: Given IV\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm I (Combination Chemotherapy, Atezolizumab)
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Atezolizumab: Given IV\>
\> Biospecimen Collection: Undergo blood sample collection\>
\> Computed Tomography: Undergo CT\>
\> Fluorouracil: Given IV\>
\> Leucovorin Calcium: Given IV\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Oxaliplatin: Given IV\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
Disease progression prior to beginning treatment
|
0
|
1
|
|
Overall Study
Patient withdrawal prior to beginning treatment
|
25
|
4
|
|
Overall Study
Unknown - prior to beginning treatment
|
2
|
0
|
|
Overall Study
Disease progression
|
13
|
5
|
|
Overall Study
Adverse Event
|
32
|
62
|
|
Overall Study
Alternative therapy
|
2
|
0
|
|
Overall Study
Complicating disease
|
2
|
0
|
|
Overall Study
Death
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
51
|
76
|
|
Overall Study
Other
|
14
|
39
|
Baseline Characteristics
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Baseline characteristics by cohort
| Measure |
Arm I (Combination Chemotherapy, Atezolizumab)
n=355 Participants
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\> \> Atezolizumab: Given IV\>
\> Biospecimen Collection: Undergo blood sample collection\>
\> Computed Tomography: Undergo CT\>
\> Fluorouracil: Given IV\>
\> Leucovorin Calcium: Given IV\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Oxaliplatin: Given IV\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm II (Combination Chemotherapy)
n=357 Participants
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.\>
\> Biospecimen Collection: Undergo blood sample collection\>
\> Computed Tomography: Undergo CT\>
\> Fluorouracil: Given IV\>
\> Leucovorin Calcium: Given IV\>
\> Magnetic Resonance Imaging: Undergo MRI\>
\> Oxaliplatin: Given IV\>
\> Quality-of-Life Assessment: Ancillary studies
|
Total
n=712 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=54 Participants
|
63 years
n=60 Participants
|
64 years
n=114 Participants
|
|
Sex: Female, Male
Female
|
186 Participants
n=54 Participants
|
206 Participants
n=60 Participants
|
392 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
169 Participants
n=54 Participants
|
151 Participants
n=60 Participants
|
320 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=54 Participants
|
22 Participants
n=60 Participants
|
46 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
322 Participants
n=54 Participants
|
320 Participants
n=60 Participants
|
642 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=54 Participants
|
15 Participants
n=60 Participants
|
24 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=54 Participants
|
12 Participants
n=60 Participants
|
22 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=54 Participants
|
22 Participants
n=60 Participants
|
50 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
302 Participants
n=54 Participants
|
305 Participants
n=60 Participants
|
607 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=54 Participants
|
15 Participants
n=60 Participants
|
27 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
341 participants
n=54 Participants
|
343 participants
n=60 Participants
|
684 participants
n=114 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=54 Participants
|
14 participants
n=60 Participants
|
28 participants
n=114 Participants
|
|
ECOG Performance Status
0
|
238 Participants
n=54 Participants
|
225 Participants
n=60 Participants
|
463 Participants
n=114 Participants
|
|
ECOG Performance Status
1
|
111 Participants
n=54 Participants
|
127 Participants
n=60 Participants
|
238 Participants
n=114 Participants
|
|
ECOG Performance Status
2
|
6 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
11 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 3 yearsDFS will be compared between treatment arms using the stratified log rank test at one-sided level 0.025. If zero DFS events are observed in a certain stratum at an interim analysis and unstratified log-rank is used, all subsequent analyses for DFS will use unstratified log-rank test. The hazard ratio (HR) for DFS will be estimated using a stratified Cox proportional hazards model and the 95 percent confidence interval (CI) for the HR will be provided. Results from an unstratified analysis will also be provided. Kaplan-Meier methodology will be used to estimate the median DFS for each treatment arm, and Kaplan-Meier curves will be produced. Brookmeyer Crowley methodology will be used to construct the 95 percent CI for the median DFS for each treatment arm.
Outcome measures
| Measure |
Arm I (Combination Chemotherapy, Atezolizumab)
n=355 Participants
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.
\>
\> Atezolizumab: Given IV
\>
\> Biospecimen Collection: Undergo blood sample collection
\>
\> Computed Tomography: Undergo CT
\>
\> Fluorouracil: Given IV
\>
\> Leucovorin Calcium: Given IV
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Oxaliplatin: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm II (Combination Chemotherapy)
n=357 Participants
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.
\>
\> Biospecimen Collection: Undergo blood sample collection
\>
\> Computed Tomography: Undergo CT
\>
\> Fluorouracil: Given IV
\>
\> Leucovorin Calcium: Given IV
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Oxaliplatin: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Disease Free Survival (DFS)
|
86.3 percentage of participants
Interval 81.8 to 89.8
|
76.2 percentage of participants
Interval 70.9 to 80.6
|
SECONDARY outcome
Timeframe: 5 yearsThe distribution of overall survival will be estimated using the method of Kaplan-Meier. Overall survival will be compared between treatment arms using the log-rank test, only if DFS is statistically significant. The HR for OS will be estimated using a Cox proportional hazards model and the 95 percent CI for the HR will be provided. If a stratified log-rank test is used, stratified HR will be considered, and if an unstratified log-rank test is used, unstratified HR will be considered.
Outcome measures
| Measure |
Arm I (Combination Chemotherapy, Atezolizumab)
n=355 Participants
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.
\>
\> Atezolizumab: Given IV
\>
\> Biospecimen Collection: Undergo blood sample collection
\>
\> Computed Tomography: Undergo CT
\>
\> Fluorouracil: Given IV
\>
\> Leucovorin Calcium: Given IV
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Oxaliplatin: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm II (Combination Chemotherapy)
n=357 Participants
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.
\>
\> Biospecimen Collection: Undergo blood sample collection
\>
\> Computed Tomography: Undergo CT
\>
\> Fluorouracil: Given IV
\>
\> Leucovorin Calcium: Given IV
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Oxaliplatin: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Survival
|
89.7 percentage of participants
Interval 85.2 to 92.9
|
87.9 percentage of participants
Interval 83.1 to 91.4
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Only patients that received treatment were included in AE analysis
Assessed by Common Terminology Criteria for Adverse Events version 4.0. The number of patients experiencing a grade 3 or greater adverse event (AE) regardless of attribution will be reported.
Outcome measures
| Measure |
Arm I (Combination Chemotherapy, Atezolizumab)
n=346 Participants
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.
\>
\> Atezolizumab: Given IV
\>
\> Biospecimen Collection: Undergo blood sample collection
\>
\> Computed Tomography: Undergo CT
\>
\> Fluorouracil: Given IV
\>
\> Leucovorin Calcium: Given IV
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Oxaliplatin: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm II (Combination Chemotherapy)
n=334 Participants
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.
\>
\> Biospecimen Collection: Undergo blood sample collection
\>
\> Computed Tomography: Undergo CT
\>
\> Fluorouracil: Given IV
\>
\> Leucovorin Calcium: Given IV
\>
\> Magnetic Resonance Imaging: Undergo MRI
\>
\> Oxaliplatin: Given IV
\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Number of Patients Experiencing Adverse Events
|
291 Participants
|
240 Participants
|
Adverse Events
Arm I (Combination Chemotherapy, Atezolizumab)
Serious events: 197 serious events
Other events: 346 other events
Deaths: 31 deaths
Arm II (Combination Chemotherapy)
Serious events: 138 serious events
Other events: 324 other events
Deaths: 33 deaths
Serious adverse events
| Measure |
Arm I (Combination Chemotherapy, Atezolizumab)
n=346 participants at risk
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial. \> \> Atezolizumab: Given IV \>
* Biospecimen Collection: Undergo blood sample collection \>
* Computed Tomography: Undergo CT \>
* Fluorouracil: Given IV \>
* Leucovorin Calcium: Given IV \>
* Magnetic Resonance Imaging: Undergo MRI \>
* Oxaliplatin: Given IV \>
* Quality-of-Life Assessment: Ancillary studies
|
Arm II (Combination Chemotherapy)
n=334 participants at risk
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial. \>
* Biospecimen Collection: Undergo blood sample collection \>
* Computed Tomography: Undergo CT \>
* Fluorouracil: Given IV \>
* Leucovorin Calcium: Given IV \>
* Magnetic Resonance Imaging: Undergo MRI \>
* Oxaliplatin: Given IV \>
* Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.87%
3/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.5%
5/334 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.2%
4/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
5/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Atrial flutter
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Cardiac arrest
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Chest pain - cardiac
|
2.3%
8/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Heart failure
|
1.2%
4/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Myocardial infarction
|
0.87%
3/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Sinus tachycardia
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Ventricular fibrillation
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Endocrine disorders
Adrenal insufficiency
|
0.87%
3/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Endocrine disorders
Hypopituitarism
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Endocrine disorders
Hypothyroidism
|
0.87%
3/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Eye disorders - Other, specify
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Watering eyes
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
13/346 • Number of events 14 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
3.3%
11/334 • Number of events 14 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Colitis
|
1.4%
5/346 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Colonic perforation
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Colonic ulcer
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Constipation
|
1.4%
5/346 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Dental caries
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Diarrhea
|
9.2%
32/346 • Number of events 50 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
7.5%
25/334 • Number of events 36 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Dyspepsia
|
0.58%
2/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Dysphagia
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Enterocolitis
|
0.87%
3/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
1.4%
5/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Jejunal ulcer
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Pancreatitis
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Proctitis
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Typhlitis
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Chills
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Death NOS
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Edema limbs
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Fever
|
3.5%
12/346 • Number of events 16 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.5%
5/334 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Flu like symptoms
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Multi-organ failure
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Non-cardiac chest pain
|
0.87%
3/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Pain
|
0.58%
2/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Sudden death NOS
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
4/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.87%
3/346 • Number of events 14 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Immune system disorders
Allergic reaction
|
1.2%
4/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Immune system disorders
Anaphylaxis
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Abdominal infection
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Bacteremia
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Device related infection
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Encephalitis infection
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Enterocolitis infectious
|
1.2%
4/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Infections and infestations - Oth spec
|
2.0%
7/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Lung infection
|
2.0%
7/346 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Pelvic infection
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Penile infection
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Pharyngitis
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Sepsis
|
2.0%
7/346 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Shingles
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Skin infection
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Thrush
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Upper respiratory infection
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Urinary tract infection
|
1.4%
5/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Wound infection
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Fall
|
0.87%
3/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Fracture
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.7%
6/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.87%
3/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 10 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
4/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Alkaline phosphatase increased
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
9/346 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Blood bilirubin increased
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Cardiac troponin I increased
|
1.7%
6/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Cholesterol high
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Creatinine increased
|
1.4%
5/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
ECG QT corrected interval prolonged
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Ejection fraction decreased
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Investigations - Other, specify
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Lipase increased
|
0.58%
2/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Serum amylase increased
|
0.29%
1/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Weight gain
|
0.87%
3/346 • Number of events 14 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Weight loss
|
0.87%
3/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Anorexia
|
1.2%
4/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.7%
6/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.2%
4/334 • Number of events 14 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.87%
3/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.87%
3/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.4%
29/346 • Number of events 51 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
4.8%
16/334 • Number of events 25 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.58%
2/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.58%
2/346 • Number of events 17 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Ataxia
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Dizziness
|
1.2%
4/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Encephalopathy
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Headache
|
1.2%
4/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Lethargy
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Paresthesia
|
1.2%
4/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.7%
9/334 • Number of events 16 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.2%
4/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.5%
5/334 • Number of events 11 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Presyncope
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Seizure
|
0.58%
2/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Stroke
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Syncope
|
1.7%
6/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.2%
4/334 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Transient ischemic attacks
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy Loss
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Confusion
|
1.2%
4/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Delirium
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Depression
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Insomnia
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
9/346 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.87%
3/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Renal calculi
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.29%
1/346 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.6%
9/346 • Number of events 10 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.5%
5/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
5/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Laryngopharyngeal dysesthesia
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.87%
3/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.58%
2/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.2%
4/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Hypertension
|
6.1%
21/346 • Number of events 37 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
8.4%
28/334 • Number of events 124 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Hypotension
|
0.87%
3/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Thromboembolic event
|
4.3%
15/346 • Number of events 54 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
4.2%
14/334 • Number of events 16 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
Other adverse events
| Measure |
Arm I (Combination Chemotherapy, Atezolizumab)
n=346 participants at risk
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial. \> \> Atezolizumab: Given IV \>
* Biospecimen Collection: Undergo blood sample collection \>
* Computed Tomography: Undergo CT \>
* Fluorouracil: Given IV \>
* Leucovorin Calcium: Given IV \>
* Magnetic Resonance Imaging: Undergo MRI \>
* Oxaliplatin: Given IV \>
* Quality-of-Life Assessment: Ancillary studies
|
Arm II (Combination Chemotherapy)
n=334 participants at risk
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial. \>
* Biospecimen Collection: Undergo blood sample collection \>
* Computed Tomography: Undergo CT \>
* Fluorouracil: Given IV \>
* Leucovorin Calcium: Given IV \>
* Magnetic Resonance Imaging: Undergo MRI \>
* Oxaliplatin: Given IV \>
* Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Eye disorders
Blurred vision
|
6.4%
22/346 • Number of events 127 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.4%
8/334 • Number of events 40 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Endocrine disorders
Adrenal insufficiency
|
0.58%
2/346 • Number of events 32 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.58%
2/346 • Number of events 25 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Endocrine disorders
Hyperparathyroidism
|
0.58%
2/346 • Number of events 17 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Endocrine disorders
Hyperthyroidism
|
3.2%
11/346 • Number of events 52 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Endocrine disorders
Hypopituitarism
|
0.29%
1/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Endocrine disorders
Hypothyroidism
|
19.7%
68/346 • Number of events 719 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
3.9%
13/334 • Number of events 84 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Sick sinus syndrome
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Sinus bradycardia
|
0.87%
3/346 • Number of events 26 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 20 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
10/346 • Number of events 16 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.4%
8/334 • Number of events 22 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Ventricular tachycardia
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Oth spec
|
0.29%
1/346 • Number of events 17 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Ear and labyrinth disorders
Ear pain
|
0.87%
3/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.29%
1/346 • Number of events 10 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.2%
4/334 • Number of events 20 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Ear and labyrinth disorders
Tinnitus
|
1.2%
4/346 • Number of events 23 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.1%
7/334 • Number of events 27 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Ear and labyrinth disorders
Vertigo
|
0.58%
2/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Blood and lymphatic system disorders
Anemia
|
46.5%
161/346 • Number of events 1549 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
44.3%
148/334 • Number of events 1051 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
2.6%
9/346 • Number of events 78 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.4%
8/334 • Number of events 45 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.87%
3/346 • Number of events 13 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.87%
3/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Atrial fibrillation
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.58%
2/346 • Number of events 19 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Chest pain - cardiac
|
1.2%
4/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Heart failure
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Cardiac disorders
Palpitations
|
0.87%
3/346 • Number of events 14 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Dry eye
|
1.7%
6/346 • Number of events 21 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.7%
9/334 • Number of events 42 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Eye disorders - Other, specify
|
1.4%
5/346 • Number of events 18 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.1%
7/334 • Number of events 14 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Eye pain
|
0.58%
2/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Eyelid function disorder
|
0.29%
1/346 • Number of events 14 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Floaters
|
0.58%
2/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Papilledema
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Periorbital edema
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Photophobia
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 13 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Retinopathy
|
0.29%
1/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Vision decreased
|
0.58%
2/346 • Number of events 13 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Eye disorders
Watering eyes
|
2.6%
9/346 • Number of events 69 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.4%
8/334 • Number of events 40 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Abdominal distension
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Abdominal pain
|
49.1%
170/346 • Number of events 972 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
34.4%
115/334 • Number of events 461 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.29%
1/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Anal mucositis
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Anal pain
|
1.2%
4/346 • Number of events 11 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Belching
|
0.29%
1/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Bloating
|
2.9%
10/346 • Number of events 67 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.1%
7/334 • Number of events 13 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Cheilitis
|
0.29%
1/346 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 12 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Colitis
|
5.8%
20/346 • Number of events 46 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Constipation
|
43.6%
151/346 • Number of events 987 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
37.4%
125/334 • Number of events 672 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Diarrhea
|
72.3%
250/346 • Number of events 1882 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
59.9%
200/334 • Number of events 1112 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Dry mouth
|
8.7%
30/346 • Number of events 172 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
6.3%
21/334 • Number of events 120 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Dyspepsia
|
10.7%
37/346 • Number of events 186 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
9.0%
30/334 • Number of events 163 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Dysphagia
|
3.5%
12/346 • Number of events 58 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
3.3%
11/334 • Number of events 42 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Enterocolitis
|
0.87%
3/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Esophagitis
|
0.58%
2/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.58%
2/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
14/346 • Number of events 68 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.5%
5/334 • Number of events 28 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.29%
1/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.29%
1/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Gastritis
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.5%
26/346 • Number of events 252 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
6.0%
20/334 • Number of events 76 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
3.5%
12/346 • Number of events 58 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.7%
9/334 • Number of events 51 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Gingival pain
|
0.87%
3/346 • Number of events 21 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
1.2%
4/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
7/346 • Number of events 31 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.2%
4/334 • Number of events 10 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Mucositis oral
|
35.5%
123/346 • Number of events 500 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
34.4%
115/334 • Number of events 427 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Nausea
|
76.6%
265/346 • Number of events 1978 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
69.5%
232/334 • Number of events 1418 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Oral dysesthesia
|
6.4%
22/346 • Number of events 141 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
3.6%
12/334 • Number of events 66 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Oral pain
|
3.2%
11/346 • Number of events 35 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.5%
5/334 • Number of events 15 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Pancreatitis
|
0.58%
2/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Proctitis
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Rectal pain
|
0.87%
3/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.58%
2/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Stomach pain
|
1.2%
4/346 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 17 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Gastrointestinal disorders
Vomiting
|
25.7%
89/346 • Number of events 256 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
19.8%
66/334 • Number of events 148 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Chills
|
5.5%
19/346 • Number of events 46 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
3.0%
10/334 • Number of events 33 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Edema face
|
0.58%
2/346 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Edema limbs
|
8.7%
30/346 • Number of events 177 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
5.7%
19/334 • Number of events 71 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Facial pain
|
0.58%
2/346 • Number of events 18 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Fatigue
|
93.4%
323/346 • Number of events 4457 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
87.7%
293/334 • Number of events 2428 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Fever
|
18.8%
65/346 • Number of events 95 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
6.3%
21/334 • Number of events 28 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Flu like symptoms
|
2.3%
8/346 • Number of events 11 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Gait disturbance
|
2.0%
7/346 • Number of events 28 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
6.1%
21/346 • Number of events 249 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
5.7%
19/334 • Number of events 76 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Generalized edema
|
0.58%
2/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Infusion site extravasation
|
0.29%
1/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Injection site reaction
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Localized edema
|
0.58%
2/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Malaise
|
1.4%
5/346 • Number of events 20 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.5%
5/334 • Number of events 34 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Neck edema
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Non-cardiac chest pain
|
2.9%
10/346 • Number of events 21 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.4%
8/334 • Number of events 20 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
General disorders
Pain
|
9.0%
31/346 • Number of events 146 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
4.2%
14/334 • Number of events 47 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Immune system disorders
Allergic reaction
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.2%
4/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.58%
2/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Bronchial infection
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Conjunctivitis
|
0.58%
2/346 • Number of events 10 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Conjunctivitis infective
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Enterocolitis infectious
|
1.2%
4/346 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Folliculitis
|
0.58%
2/346 • Number of events 14 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Hepatitis B reactivation
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Herpes simplex reactivation
|
1.7%
6/346 • Number of events 12 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Infections and infestations - Oth spec
|
5.5%
19/346 • Number of events 33 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.4%
8/334 • Number of events 10 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Lip infection
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Lung infection
|
1.4%
5/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Mucosal infection
|
0.58%
2/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Myelitis
|
0.29%
1/346 • Number of events 11 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Nail infection
|
0.58%
2/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Otitis media
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Papulopustular rash
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Paronychia
|
0.29%
1/346 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Rash pustular
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Rhinitis infective
|
0.29%
1/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Salivary gland infection
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Sepsis
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Shingles
|
0.58%
2/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Sinusitis
|
0.29%
1/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Skin infection
|
1.4%
5/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.2%
4/334 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Soft tissue infection
|
0.29%
1/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Thrush
|
5.5%
19/346 • Number of events 90 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
3.9%
13/334 • Number of events 28 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Tooth infection
|
0.58%
2/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Upper respiratory infection
|
1.4%
5/346 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Urinary tract infection
|
11.3%
39/346 • Number of events 101 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
7.2%
24/334 • Number of events 49 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Vaginal infection
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Infections and infestations
Wound infection
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Bruising
|
3.2%
11/346 • Number of events 37 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.1%
7/334 • Number of events 20 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
8/346 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.2%
4/334 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Fracture
|
0.29%
1/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.1%
35/346 • Number of events 44 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
6.3%
21/334 • Number of events 26 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.2%
4/346 • Number of events 13 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Alanine aminotransferase increased
|
29.5%
102/346 • Number of events 580 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
25.1%
84/334 • Number of events 401 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Alkaline phosphatase increased
|
30.3%
105/346 • Number of events 979 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
30.2%
101/334 • Number of events 594 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Aspartate aminotransferase increased
|
34.7%
120/346 • Number of events 880 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
35.6%
119/334 • Number of events 623 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Blood bilirubin increased
|
10.4%
36/346 • Number of events 206 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
6.9%
23/334 • Number of events 84 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.4%
5/346 • Number of events 38 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 14 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Blood prolactin abnormal
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
CPK increased
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Cardiac troponin I increased
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Cholesterol high
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Creatinine increased
|
10.7%
37/346 • Number of events 176 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
4.5%
15/334 • Number of events 49 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Hemoglobin increased
|
0.29%
1/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
INR increased
|
0.87%
3/346 • Number of events 14 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Investigations - Other, specify
|
4.6%
16/346 • Number of events 142 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
5.7%
19/334 • Number of events 132 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Lipase increased
|
1.7%
6/346 • Number of events 11 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 15 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Lymphocyte count decreased
|
20.8%
72/346 • Number of events 510 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
13.8%
46/334 • Number of events 195 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Lymphocyte count increased
|
1.2%
4/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Neutrophil count decreased
|
74.0%
256/346 • Number of events 1154 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
67.4%
225/334 • Number of events 838 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Pancreatic enzymes decreased
|
0.29%
1/346 • Number of events 20 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Platelet count decreased
|
68.2%
236/346 • Number of events 2469 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
66.8%
223/334 • Number of events 1570 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Serum amylase increased
|
0.87%
3/346 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Thyroid stimulating hormone increased
|
3.5%
12/346 • Number of events 75 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Weight gain
|
2.9%
10/346 • Number of events 101 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.8%
6/334 • Number of events 20 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
Weight loss
|
13.6%
47/346 • Number of events 334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
8.1%
27/334 • Number of events 142 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Investigations
White blood cell decreased
|
39.3%
136/346 • Number of events 791 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
40.1%
134/334 • Number of events 525 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Anorexia
|
49.7%
172/346 • Number of events 1049 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
38.9%
130/334 • Number of events 702 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Dehydration
|
7.5%
26/346 • Number of events 42 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
6.0%
20/334 • Number of events 58 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.87%
3/346 • Number of events 10 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.87%
3/346 • Number of events 10 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.4%
8/334 • Number of events 11 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
19.1%
66/346 • Number of events 573 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
9.9%
33/334 • Number of events 164 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.5%
12/346 • Number of events 50 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.29%
1/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.2%
11/346 • Number of events 38 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.4%
8/334 • Number of events 13 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.29%
1/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.8%
58/346 • Number of events 289 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
11.7%
39/334 • Number of events 200 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.0%
31/346 • Number of events 73 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
5.4%
18/334 • Number of events 67 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.3%
8/346 • Number of events 13 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.3%
77/346 • Number of events 284 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
20.4%
68/334 • Number of events 239 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.9%
24/346 • Number of events 130 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
5.1%
17/334 • Number of events 68 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.6%
40/346 • Number of events 100 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
6.3%
21/334 • Number of events 61 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.87%
3/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.58%
2/346 • Number of events 23 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 11 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.1%
35/346 • Number of events 299 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
3.6%
12/334 • Number of events 55 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.87%
3/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
14/346 • Number of events 50 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.4%
8/334 • Number of events 30 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
6/346 • Number of events 38 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.1%
7/334 • Number of events 31 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.29%
1/346 • Number of events 10 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.58%
2/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.4%
29/346 • Number of events 138 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
3.3%
11/334 • Number of events 45 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
4.0%
14/346 • Number of events 59 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.1%
7/334 • Number of events 23 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.2%
4/346 • Number of events 19 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
1.7%
6/346 • Number of events 18 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.1%
7/334 • Number of events 24 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.5%
19/346 • Number of events 86 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
3.6%
12/334 • Number of events 55 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.87%
3/346 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.5%
19/346 • Number of events 65 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
4.5%
15/334 • Number of events 60 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.58%
2/346 • Number of events 10 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
1.2%
4/346 • Number of events 28 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Anosmia
|
0.58%
2/346 • Number of events 38 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Cognitive disturbance
|
0.87%
3/346 • Number of events 19 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 23 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Concentration impairment
|
0.87%
3/346 • Number of events 13 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Dizziness
|
12.4%
43/346 • Number of events 219 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
9.9%
33/334 • Number of events 120 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Dysesthesia
|
8.1%
28/346 • Number of events 232 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
7.8%
26/334 • Number of events 174 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Dysgeusia
|
27.7%
96/346 • Number of events 907 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
25.1%
84/334 • Number of events 487 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Encephalopathy
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Headache
|
15.0%
52/346 • Number of events 227 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
11.7%
39/334 • Number of events 130 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Hypersomnia
|
0.29%
1/346 • Number of events 17 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Lethargy
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Memory impairment
|
4.0%
14/346 • Number of events 146 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.4%
8/334 • Number of events 21 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
2.3%
8/346 • Number of events 47 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.1%
7/334 • Number of events 10 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Neuralgia
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.2%
4/334 • Number of events 16 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Paresthesia
|
26.6%
92/346 • Number of events 1049 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
29.9%
100/334 • Number of events 736 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.4%
22/346 • Number of events 193 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
6.3%
21/334 • Number of events 121 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
77.2%
267/346 • Number of events 4068 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
69.8%
233/334 • Number of events 1947 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Presyncope
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Somnolence
|
0.58%
2/346 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Spasticity
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 13 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Syncope
|
1.2%
4/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Transient ischemic attacks
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Tremor
|
1.2%
4/346 • Number of events 18 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 15 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Nervous system disorders
Vasovagal reaction
|
0.58%
2/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Agitation
|
0.87%
3/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Anxiety
|
4.0%
14/346 • Number of events 46 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
4.5%
15/334 • Number of events 89 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Confusion
|
1.2%
4/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Delirium
|
0.29%
1/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Depression
|
1.7%
6/346 • Number of events 59 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 24 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Hallucinations
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Insomnia
|
9.2%
32/346 • Number of events 237 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
9.3%
31/334 • Number of events 148 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Acute kidney injury
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.0%
7/346 • Number of events 51 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.87%
3/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.8%
6/334 • Number of events 12 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Glucosuria
|
0.87%
3/346 • Number of events 23 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Hematuria
|
2.6%
9/346 • Number of events 61 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Proteinuria
|
3.8%
13/346 • Number of events 65 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 14 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.87%
3/346 • Number of events 19 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.2%
4/334 • Number of events 20 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Urinary frequency
|
0.87%
3/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.5%
5/334 • Number of events 20 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Urinary incontinence
|
0.87%
3/346 • Number of events 12 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Urinary tract pain
|
0.29%
1/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Urinary urgency
|
0.87%
3/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Renal and urinary disorders
Urine discoloration
|
0.58%
2/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Reproductive system and breast disorders
Ovarian rupture
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.29%
1/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.29%
1/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.87%
3/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.0%
7/346 • Number of events 15 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.2%
4/334 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
43.9%
152/346 • Number of events 840 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
24.3%
81/334 • Number of events 341 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.1%
125/346 • Number of events 1103 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
24.6%
82/334 • Number of events 382 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.0%
31/346 • Number of events 138 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
9.0%
30/334 • Number of events 122 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.0%
7/346 • Number of events 23 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.4%
8/334 • Number of events 27 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.2%
4/346 • Number of events 12 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.5%
5/334 • Number of events 36 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.58%
2/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.29%
1/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Laryngopharyngeal dysesthesia
|
1.2%
4/346 • Number of events 19 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.7%
9/334 • Number of events 36 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.9%
10/346 • Number of events 32 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.5%
5/334 • Number of events 11 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.58%
2/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
6/346 • Number of events 13 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.87%
3/346 • Number of events 5 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
1.7%
6/346 • Number of events 18 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.0%
7/346 • Number of events 39 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.8%
6/334 • Number of events 21 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.58%
2/346 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.1%
21/346 • Number of events 53 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
3.6%
12/334 • Number of events 43 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.29%
1/346 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
52/346 • Number of events 547 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
18.6%
62/334 • Number of events 447 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Body odor
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.2%
32/346 • Number of events 241 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
6.3%
21/334 • Number of events 113 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.87%
3/346 • Number of events 35 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/346 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 10 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.6%
9/346 • Number of events 51 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.29%
1/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.9%
10/346 • Number of events 106 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.2%
4/334 • Number of events 15 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.29%
1/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 19 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
1.2%
4/346 • Number of events 12 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.2%
4/334 • Number of events 22 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.58%
2/346 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
14.5%
50/346 • Number of events 343 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
12.9%
43/334 • Number of events 201 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.87%
3/346 • Number of events 17 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.60%
2/334 • Number of events 8 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.8%
58/346 • Number of events 343 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
6.0%
20/334 • Number of events 78 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.2%
18/346 • Number of events 68 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.4%
8/334 • Number of events 21 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.9%
48/346 • Number of events 206 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
6.0%
20/334 • Number of events 46 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
1.4%
5/346 • Number of events 34 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 7 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
9.5%
33/346 • Number of events 212 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
3.6%
12/334 • Number of events 48 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.0%
14/346 • Number of events 133 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
3.3%
11/334 • Number of events 75 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.29%
1/346 • Number of events 23 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.87%
3/346 • Number of events 18 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Flushing
|
2.9%
10/346 • Number of events 56 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.8%
6/334 • Number of events 23 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Hematoma
|
0.29%
1/346 • Number of events 1 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 4 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Hot flashes
|
3.5%
12/346 • Number of events 60 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
2.1%
7/334 • Number of events 16 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Hypertension
|
13.0%
45/346 • Number of events 360 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
13.2%
44/334 • Number of events 263 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Hypotension
|
4.9%
17/346 • Number of events 41 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
1.8%
6/334 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Phlebitis
|
0.29%
1/346 • Number of events 3 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.29%
1/346 • Number of events 2 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.00%
0/334 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Thromboembolic event
|
5.5%
19/346 • Number of events 188 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.90%
3/334 • Number of events 9 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.29%
1/346 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
0.30%
1/334 • Number of events 6 • 5 years
All patients included in mortality assessment; only patients that received treatment included in adverse event reporting
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60