Trial Outcomes & Findings for Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients (NCT NCT01934452)
NCT ID: NCT01934452
Last Updated: 2023-11-13
Results Overview
In this outcome measure, participants were categorized according to radiological assessment of the CR. It included: disappearance of all known target lesions, disappearance of all non-target lesions, no new lesions and all target and non-target lymph nodes. Only those categories with at least 1 participant as result are reported. As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).
Recruitment status
COMPLETED
Target enrollment
77 participants
Primary outcome timeframe
From initiation of sunitinib till CR (data collected at Inclusion Visit)
Results posted on
2023-11-13
Participant Flow
Participants diagnosed with metastatic renal cell carcinoma (mRCC), aged above 18 years treated with sunitinib, were included in this study and their data was observed prospectively.
Participant milestones
| Measure |
Sunitinib: Complete Remission (Cases)
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
42
|
|
Overall Study
COMPLETED
|
35
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=42 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 9.1 • n=35 Participants
|
60.3 Years
STANDARD_DEVIATION 10.1 • n=42 Participants
|
60.4 Years
STANDARD_DEVIATION 9.6 • n=77 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=35 Participants
|
11 Participants
n=42 Participants
|
20 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=35 Participants
|
31 Participants
n=42 Participants
|
57 Participants
n=77 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline (at inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study.
Time to diagnose metastatic renal cell carcinoma was defined as the duration between date of diagnosis of mRCC to date of inclusion visit.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=42 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Time to Diagnose Metastatic Renal Cell Carcinoma
|
3.79 Years
Interval 2.39 to 5.42
|
0.21 Years
Interval 0.09 to 0.82
|
PRIMARY outcome
Timeframe: Baseline (at inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study.
In this outcome measure, participants were categorized according to presence of nephrectomy as yes or no.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=42 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Presence of Nephrectomy
Yes
|
35 Participants
|
31 Participants
|
|
Number of Participants Categorized According to Presence of Nephrectomy
No
|
0 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Baseline (at inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable with non-missing values for specific rows.
In this outcome measure, participants were categorized according to type of nephrectomy. Various types of nephrectomies included: extended or partial, nephrectomy with or without adrenalectomy, nephrectomy with or without curettage and open or laparoscopic nephrectomy.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=31 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Type of Nephrectomy
Extended or partial nephrectomy: Extended
|
30 Participants
|
28 Participants
|
|
Number of Participants Categorized According to Type of Nephrectomy
Extended or partial nephrectomy: Partial
|
4 Participants
|
3 Participants
|
|
Number of Participants Categorized According to Type of Nephrectomy
Nephrectomy with or without curettage: Without curettage
|
21 Participants
|
23 Participants
|
|
Number of Participants Categorized According to Type of Nephrectomy
Open or laparoscopic nephrectomy: Laparoscopic nephrectomy
|
5 Participants
|
5 Participants
|
|
Number of Participants Categorized According to Type of Nephrectomy
Open or laparoscopic nephrectomy: Open nephrectomy
|
21 Participants
|
16 Participants
|
|
Number of Participants Categorized According to Type of Nephrectomy
Nephrectomy with or without adrenalectomy: With adrenalectomy
|
15 Participants
|
11 Participants
|
|
Number of Participants Categorized According to Type of Nephrectomy
Nephrectomy with or without adrenalectomy: Without adrenalectomy
|
18 Participants
|
15 Participants
|
|
Number of Participants Categorized According to Type of Nephrectomy
Nephrectomy with or without curettage: With curettage
|
11 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline (at inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
In this outcome measure, time from diagnosis of mRCC to nephrectomy was reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=33 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=28 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Time to Nephrectomy From Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
|
5.7 Months
Interval -0.5 to 20.3
|
10.0 Months
Interval -0.4 to 29.6
|
PRIMARY outcome
Timeframe: Baseline (at inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study.
In this outcome measure, participants were categorized according to pathological classification. Pathological classification included: clear cell carcinoma (yes or no), multilocular cystic renal clear cell carcinoma (yes or no), papillary cell carcinoma (yes or no), chromophobe cell carcinoma(yes or no), Bellini's collecting duct carcinoma(yes or no), medullary cell carcinoma (yes or no), sarcomatoid contingent (yes or no), and other (yes or no).
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=42 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Pathological Classification
Clear cell carcinoma · No
|
2 Participants
|
3 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Multilocular cystic renal clear cell carcinoma · No
|
34 Participants
|
41 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Papillary cell carcinoma · Yes
|
1 Participants
|
4 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Papillary cell carcinoma · No
|
34 Participants
|
38 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Chromophobe cell carcinoma · No
|
34 Participants
|
42 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Bellini's collecting duct carcinoma · No
|
35 Participants
|
41 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Sarcomatoid contingent · Yes
|
4 Participants
|
3 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Sarcomatoid contingent · No
|
31 Participants
|
39 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Other · No
|
32 Participants
|
40 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Clear cell carcinoma · Yes
|
33 Participants
|
39 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Multilocular cystic renal clear cell carcinoma · Yes
|
1 Participants
|
1 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Chromophobe cell carcinoma · Yes
|
1 Participants
|
0 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Bellini's collecting duct carcinoma · Yes
|
0 Participants
|
1 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Medullary cell carcinoma · Yes
|
0 Participants
|
0 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Medullary cell carcinoma · No
|
35 Participants
|
42 Participants
|
|
Number of Participants Categorized According to Pathological Classification
Other · Yes
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline (at inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable with non-missing value for specific rows.
In this outcome measure, participants were categorized according to TNM classification. TNM classification included: T class (1, 2, 3, 4), N (0,1,2, x) and M class (0, 1). TNM system is based on size of primary tumor (T), amount of spread to lymph nodes (N) and presence of metastases (M). T1: tumor (less than or equal to) \<=20 millimeters (mm), T2: tumor \>20 mm to \<=50 mm, T3: \>50 mm, T4: tumor invading other structures. N0: no lymph node metastases, N1: metastases to ipsilateral level I, II axillary lymph nodes, NX: Regional lymph nodes cannot be assessed. M0: no clinical/radiographic evidence of distant metastases, M1: distant detectable metastases as determined by clinical and radiographic means and/or histologically proven \>0.2 mm.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=34 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=34 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification
N Class: NX
|
8 Participants
|
6 Participants
|
|
Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification
T Class: T1
|
8 Participants
|
8 Participants
|
|
Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification
T Class: T2
|
7 Participants
|
8 Participants
|
|
Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification
T Class: T3
|
18 Participants
|
15 Participants
|
|
Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification
T Class: T4
|
1 Participants
|
3 Participants
|
|
Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification
N Class: N0
|
12 Participants
|
10 Participants
|
|
Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification
N Class: N1
|
1 Participants
|
3 Participants
|
|
Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification
N Class: N2
|
2 Participants
|
2 Participants
|
|
Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification
M Class: M0
|
19 Participants
|
15 Participants
|
|
Number of Participants Categorized According to Tumor, Node, Metastasis (TNM) Classification
M Class: M1
|
13 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Baseline (at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Tumour size of participants was reported in this outcome measure.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=34 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=34 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Tumour Size
|
73.0 Millimeter
Interval 48.0 to 110.0
|
75.5 Millimeter
Interval 50.0 to 100.0
|
PRIMARY outcome
Timeframe: Baseline (at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure with non-missing values.
In this outcome measure, participants were categorized according to Fuhrman nuclear grade. The grades were classified as: grade 1, 2, 3, and 4. The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer \[mcm\]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at \*400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at \*100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=33 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=34 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Fuhrman Nuclear Grade
Grade 1
|
2 Participants
|
4 Participants
|
|
Number of Participants Categorized According to Fuhrman Nuclear Grade
Grade 2
|
9 Participants
|
11 Participants
|
|
Number of Participants Categorized According to Fuhrman Nuclear Grade
Grade 3
|
14 Participants
|
12 Participants
|
|
Number of Participants Categorized According to Fuhrman Nuclear Grade
Grade 4
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline (at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure with non-missing values and "number analyzed" signifies participants evaluable at specific rows.
In this outcome measure, participants were categorized according to presence of necrosis, pulmonary embolism and sarcomatoid component.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=34 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=33 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Presence of Necrosis, Pulmonary Embolism and Sarcomatoid Component
Sarcomatoid component · No
|
29 Participants
|
28 Participants
|
|
Number of Participants Categorized According to Presence of Necrosis, Pulmonary Embolism and Sarcomatoid Component
Presence of necrosis · Yes
|
14 Participants
|
20 Participants
|
|
Number of Participants Categorized According to Presence of Necrosis, Pulmonary Embolism and Sarcomatoid Component
Presence of necrosis · No
|
19 Participants
|
11 Participants
|
|
Number of Participants Categorized According to Presence of Necrosis, Pulmonary Embolism and Sarcomatoid Component
Vascular embolism · Yes
|
12 Participants
|
12 Participants
|
|
Number of Participants Categorized According to Presence of Necrosis, Pulmonary Embolism and Sarcomatoid Component
Vascular embolism · No
|
20 Participants
|
16 Participants
|
|
Number of Participants Categorized According to Presence of Necrosis, Pulmonary Embolism and Sarcomatoid Component
Sarcomatoid component · Yes
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Diagnosis of mRCC to Sunitinib Initiation (at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure with non-missing values.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=33 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=39 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Time to Initiation of Sunitinib From Diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
|
3.25 Months
Interval 1.54 to 6.47
|
2.69 Months
Interval 1.81 to 9.82
|
PRIMARY outcome
Timeframe: At initiation of sunitinib (at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study.
In this outcome measure, participants were categorized according to location of metastases at different body parts (lung, bones, liver, adrenal gland, pancreas, brain and lymph nodes). Participant can have more than 1 location of metastases.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=42 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Location of Metastases
Lung · Yes
|
15 Participants
|
30 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Lung · No
|
20 Participants
|
12 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Bones · Yes
|
5 Participants
|
12 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Bones · No
|
30 Participants
|
30 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Liver · Yes
|
6 Participants
|
10 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Liver · No
|
29 Participants
|
32 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Adrenal glands · Yes
|
2 Participants
|
8 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Adrenal glands · No
|
33 Participants
|
34 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Pancreas · Yes
|
2 Participants
|
5 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Pancreas · No
|
33 Participants
|
37 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Brain · Yes
|
0 Participants
|
3 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Brain · No
|
35 Participants
|
39 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Lymph nodes · Yes
|
11 Participants
|
23 Participants
|
|
Number of Participants Categorized According to Location of Metastases
Lymph nodes · No
|
24 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: At initiation of sunitinib (at Initiation Visit)Population: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific rows.
In this outcome measure, participants were categorized according to type of lymph nodes as metastatic site.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=11 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=23 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site
Supradiaphragmatic · Yes
|
7 Participants
|
16 Participants
|
|
Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site
Supradiaphragmatic · No
|
3 Participants
|
7 Participants
|
|
Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site
Infradiaphragmatic · Yes
|
3 Participants
|
11 Participants
|
|
Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site
Infradiaphragmatic · No
|
8 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: At initiation of sunitinib (at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study.
In this outcome measure, participants were categorized according to recurrence at nephrectomy site were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=42 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Recurrence at Nephrectomy Site
No
|
29 Participants
|
41 Participants
|
|
Number of Participants Categorized According to Recurrence at Nephrectomy Site
Yes
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At initiation of sunitinib (at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study.
In this outcome measure, participants were categorized according to recurrence at any other site than nephrectomy site were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=42 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Recurrence at Other Site
Yes
|
3 Participants
|
12 Participants
|
|
Number of Participants Categorized According to Recurrence at Other Site
No
|
32 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: At initiation of sunitinib (at Initiation Visit)Population: Analysis population included all eligible participants whose data were observed in the study.
In this outcome measure, median of metastatic sites were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=42 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Metastatic Sites
|
1.0 Metastatic sites
Interval 1.0 to 2.0
|
2.0 Metastatic sites
Interval 2.0 to 4.0
|
PRIMARY outcome
Timeframe: At initiation of sunitinib (at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure with non-missing values.
In this outcome measure, participants were categorized according MSKCC prognostic classification. MSKCC criteria had 5 risk factors: Karnofsky performance status (KPS) \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; hemoglobin \<lower limit of normal (LLN); lactate dehydrogenase \>1.5\*upper limit of normal (ULN); corrected serum calcium \>10 milligram per deciliter (mg/dL). Present risk factors were added, and participants were stratified as: good prognosis (0 factor), intermediate prognosis (1-2 factors), poor prognosis (\>=2 factors).
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=26 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=38 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Classification
Good prognosis
|
14 Participants
|
8 Participants
|
|
Number of Participants Categorized According to Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Classification
Poor prognosis
|
0 Participants
|
6 Participants
|
|
Number of Participants Categorized According to Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Classification
Intermediate prognosis
|
12 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: From initiation of sunitinib till CR (data collected at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, time taken by participants to achieve the complete remission after sunitinib initiation were reported. As per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to size of \<10 millimeter (mm).
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Time to Achieve Complete Remission (CR) After Sunitinib Initiation: mRCC Participants With CR
|
0.98 Years
Interval -0.8 to 8.0
|
—
|
PRIMARY outcome
Timeframe: From initiation of sunitinib till CR (data collected at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants were categorized according to the method of achieving the CR. Different methods included: treatment combined with local treatment and medical treatment alone. As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Method of Achieving CR: mRCC Participants With CR
Treatment combined with local treatment
|
14 Participants
|
—
|
|
Number of Participants Categorized According to Method of Achieving CR: mRCC Participants With CR
Medical treatment alone
|
21 Participants
|
—
|
PRIMARY outcome
Timeframe: From initiation of sunitinib till CR (data collected at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants were categorized according to the type of medical treatment alone as method of achieving the CR. Medical treatment alone included: surgery, radiotherapy, radiofrequency, cryoablation and metastasectomy. Only those categories in which at least 1 participant had data were reported. Participant could have received more than 1 type of medical treatment. As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=14 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Type of Medical Treatment Alone: mRCC Participants With CR
Surgery
|
5 Participants
|
—
|
|
Number of Participants Categorized According to Type of Medical Treatment Alone: mRCC Participants With CR
Radiotherapy
|
2 Participants
|
—
|
|
Number of Participants Categorized According to Type of Medical Treatment Alone: mRCC Participants With CR
Radiofrequency
|
2 Participants
|
—
|
|
Number of Participants Categorized According to Type of Medical Treatment Alone: mRCC Participants With CR
Metastasectomy
|
8 Participants
|
—
|
|
Number of Participants Categorized According to Type of Medical Treatment Alone: mRCC Participants With CR
Other
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: From initiation of sunitinib till CR (data collected at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants were categorized according to the type of treatment Combined With local treatment alone as method of achieving the CR. Type of treatment combined with local treatment included: surgery, surgery + radiotherapy + radiofrequency + metastasectomy, metastasectomy, metastasectomy + other, radiofrequency + metastasectomy + other and radiotherapy. As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=14 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Treatment Combined With Local Treatment: mRCC Participants With CR
Other
|
1 Participants
|
—
|
|
Number of Participants Categorized According to Treatment Combined With Local Treatment: mRCC Participants With CR
Surgery
|
4 Participants
|
—
|
|
Number of Participants Categorized According to Treatment Combined With Local Treatment: mRCC Participants With CR
Surgery + Radiotherapy + Radiofrequency + Metastasectomy
|
1 Participants
|
—
|
|
Number of Participants Categorized According to Treatment Combined With Local Treatment: mRCC Participants With CR
Metastasectomy + Other
|
1 Participants
|
—
|
|
Number of Participants Categorized According to Treatment Combined With Local Treatment: mRCC Participants With CR
Metastasectomy
|
5 Participants
|
—
|
|
Number of Participants Categorized According to Treatment Combined With Local Treatment: mRCC Participants With CR
Radiofrequency + Metastasectomy + Other
|
1 Participants
|
—
|
|
Number of Participants Categorized According to Treatment Combined With Local Treatment: mRCC Participants With CR
Radiotherapy
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: From initiation of sunitinib till CR (data collected at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. Here, "number analyzed" signifies participants evaluable with non-missing values for specified rows. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants were categorized according to radiological assessment of the CR. It included: disappearance of all known target lesions, disappearance of all non-target lesions, no new lesions and all target and non-target lymph nodes. Only those categories with at least 1 participant as result are reported. As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Radiological Assessment of the CR: mRCC Participants With CR
Disappearance of all known target lesions: yes
|
35 Participants
|
—
|
|
Number of Participants Categorized According to Radiological Assessment of the CR: mRCC Participants With CR
Disappearance of all non-target lesions: yes
|
34 Participants
|
—
|
|
Number of Participants Categorized According to Radiological Assessment of the CR: mRCC Participants With CR
No new lesions: yes
|
34 Participants
|
—
|
|
Number of Participants Categorized According to Radiological Assessment of the CR: mRCC Participants With CR
No new lesions: no
|
1 Participants
|
—
|
|
Number of Participants Categorized According to Radiological Assessment of the CR: mRCC Participants With CR
All target and non-target lymph nodes: yes
|
34 Participants
|
—
|
PRIMARY outcome
Timeframe: After achieving CR with sunitinib treatment (data collected at Inclusion Visit)Population: Analysis population included all eligible participants whose data were observed in the study. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants were categorized according to therapeutic strategy after CR. As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). It included discontinuation and continuation of sunitinib treatment.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Therapeutic Strategy After CR: mRCC Participants With CR
Discontinuation of Sunitinib treatment
|
16 Participants
|
—
|
|
Number of Participants Categorized According to Therapeutic Strategy After CR: mRCC Participants With CR
Continuation of Sunitinib treatment
|
19 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 12 follow-up visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure with non-missing values. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
DE included:complete response, progression, stabilization and not assessed. Disease progression (PD):per RECIST v1.1: at least 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study.In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm.Appearance of 1 or more new lesions was also considered progression. CR:disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis) and stable disease (SD): absence of sufficient reduction for a partial response (PR): at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters or absence of a sufficient increase for PD, taking as reference the sum of lowest diameters during study.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=31 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants With Disease Evolution (DE) at Month 12 Follow-up Visit: mRCC Participants With CR
Complete response
|
21 Participants
|
—
|
|
Number of Participants With Disease Evolution (DE) at Month 12 Follow-up Visit: mRCC Participants With CR
Progression
|
5 Participants
|
—
|
|
Number of Participants With Disease Evolution (DE) at Month 12 Follow-up Visit: mRCC Participants With CR
Stabilization
|
3 Participants
|
—
|
|
Number of Participants With Disease Evolution (DE) at Month 12 Follow-up Visit: mRCC Participants With CR
Not assessed
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 12 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure with non-missing values. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants with ongoing sunitinib treatment were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=29 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants With Ongoing Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
Yes
|
9 Participants
|
—
|
|
Number of Participants With Ongoing Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
No
|
20 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 12 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants with ongoing sunitinib treatment according to dose (25, 37.5 and 50 mg) and regimen (4/2 \[4 weeks dosing then 2 weeks off\] and 2/1 \[4 weeks dosing then 2 weeks off\]) were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=9 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants With Ongoing Sunitinib Treatment According to Dose and Regimen at Month 12 Follow-up Visit: mRCC Participants With CR
Current dose: 25 mg
|
1 Participants
|
—
|
|
Number of Participants With Ongoing Sunitinib Treatment According to Dose and Regimen at Month 12 Follow-up Visit: mRCC Participants With CR
Current dose: 37.5 mg
|
4 Participants
|
—
|
|
Number of Participants With Ongoing Sunitinib Treatment According to Dose and Regimen at Month 12 Follow-up Visit: mRCC Participants With CR
Current dose: 50 mg
|
4 Participants
|
—
|
|
Number of Participants With Ongoing Sunitinib Treatment According to Dose and Regimen at Month 12 Follow-up Visit: mRCC Participants With CR
Current regimen: 4/2
|
1 Participants
|
—
|
|
Number of Participants With Ongoing Sunitinib Treatment According to Dose and Regimen at Month 12 Follow-up Visit: mRCC Participants With CR
Current regimen: 2/1
|
6 Participants
|
—
|
|
Number of Participants With Ongoing Sunitinib Treatment According to Dose and Regimen at Month 12 Follow-up Visit: mRCC Participants With CR
Current regimen: other
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 12 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants who temporarily discontinued sunitinib were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=26 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Who Discontinued Sunitinib Temporarily at Month 12 Follow-up Visit: mRCC Participants With CR
Yes
|
5 Participants
|
—
|
|
Number of Participants Who Discontinued Sunitinib Temporarily at Month 12 Follow-up Visit: mRCC Participants With CR
No
|
21 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 12 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants were categorized according to number (1 and 2) of temporary discontinuations of sunitinib.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=5 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Number of Temporary Discontinuations of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
1-time temporary discontinuation
|
3 Participants
|
—
|
|
Number of Participants Categorized According to Number of Temporary Discontinuations of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
2-times temporary discontinuation
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 12 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, number of instances when different types of reasons led to temporary discontinuations like intolerance, local treatment and other reasons were reported. Participant could have temporarily discontinued sunitinib treatment more than once.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=5 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Instances When Different Types of Reason Led to Temporary Discontinuation of Sunitinib Treatment at Month 12 Follow up Visit: mRCC Participants With CR
Intolerance
|
3 Instances
|
—
|
|
Number of Instances When Different Types of Reason Led to Temporary Discontinuation of Sunitinib Treatment at Month 12 Follow up Visit: mRCC Participants With CR
Local treatment
|
1 Instances
|
—
|
|
Number of Instances When Different Types of Reason Led to Temporary Discontinuation of Sunitinib Treatment at Month 12 Follow up Visit: mRCC Participants With CR
Others
|
3 Instances
|
—
|
PRIMARY outcome
Timeframe: Month 12 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, number of instances when participants resumed sunitinib treatment were reported. Participant could have temporarily discontinued sunitinib treatment more than once and likewise resumed treatment more than once.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=5 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Instances When Participants Resumed Sunitinib Treatment After Temporary Discontinuation at Month 12: mRCC Participants With CR
Resumed: yes
|
6 Instances
|
—
|
|
Number of Instances When Participants Resumed Sunitinib Treatment After Temporary Discontinuation at Month 12: mRCC Participants With CR
Resumed: no
|
1 Instances
|
—
|
PRIMARY outcome
Timeframe: Month 12 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, duration of temporary discontinuation of sunitinib treatment were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=5 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Duration of Temporary Discontinuation of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
|
15.0 Days
Interval 4.0 to 93.0
|
—
|
PRIMARY outcome
Timeframe: Month 12 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure with non-missing values. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, number of participants who permanently discontinued sunitinib were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=27 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Who Discontinued Sunitinib Permanently at Month 12 Follow-up Visit: mRCC Participants With CR
Yes
|
10 Participants
|
—
|
|
Number of Participants Who Discontinued Sunitinib Permanently at Month 12 Follow-up Visit: mRCC Participants With CR
No
|
17 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 12 follow-up visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants were categorized according to reasons for permanent discontinuation of sunitinib.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=10 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
Intolerance
|
1 Participants
|
—
|
|
Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
Complete response retention
|
7 Participants
|
—
|
|
Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
Decision of participant or doctor
|
1 Participants
|
—
|
|
Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 12 Follow-up Visit: mRCC Participants With CR
Other
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 12 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 12 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, duration of treatment with sunitinib since complete remission was reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=8 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Duration of Treatment With Sunitinib Since Complete Remission at Month 12 Follow-up Visit: mRCC Participants With CR
|
6.00 Months
Interval 0.0 to 37.1
|
—
|
PRIMARY outcome
Timeframe: Month 24 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure with non-missing values. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
DE included: CR, PD, SD and not assessed. PD: per RECIST v1.1: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm. Appearance of one or more new lesions was also considered progression. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).SD: absence of sufficient reduction for PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters or absence of a sufficient increase for PD, taking as reference the sum of lowest diameters during study.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=26 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants With Disease Evolution at Month 24 Follow-up Visit: mRCC Participants With CR
Complete response
|
19 Participants
|
—
|
|
Number of Participants With Disease Evolution at Month 24 Follow-up Visit: mRCC Participants With CR
Progression
|
4 Participants
|
—
|
|
Number of Participants With Disease Evolution at Month 24 Follow-up Visit: mRCC Participants With CR
Stabilization
|
1 Participants
|
—
|
|
Number of Participants With Disease Evolution at Month 24 Follow-up Visit: mRCC Participants With CR
Not assessed
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 24 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants with ongoing sunitinib treatment were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=25 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants With Ongoing Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR
Yes
|
4 Participants
|
—
|
|
Number of Participants With Ongoing Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR
No
|
21 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 24 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, number of participants who temporarily discontinued sunitinib were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=23 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Who Discontinued Sunitinib Temporarily at Month 24 Follow-up Visit: mRCC Participants With CR
Yes
|
2 Participants
|
—
|
|
Number of Participants Who Discontinued Sunitinib Temporarily at Month 24 Follow-up Visit: mRCC Participants With CR
No
|
21 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 24 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants who resumed sunitinib were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=1 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Who Resumed Treatment at Month 24 Follow-up Visit: mRCC Participants With CR
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 24 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=1 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Days of Temporary Discontinuation of Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR
|
15 Days
|
—
|
PRIMARY outcome
Timeframe: Month 24 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=23 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Who Discontinued Sunitinib Permanently at Month 24 Follow-up Visit: mRCC Participants With CR
Yes
|
11 Participants
|
—
|
|
Number of Participants Who Discontinued Sunitinib Permanently at Month 24 Follow-up Visit: mRCC Participants With CR
No
|
12 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 24 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=11 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR
Progression
|
1 Participants
|
—
|
|
Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR
Intolerance
|
3 Participants
|
—
|
|
Number of Participants Categorized According to Reasons for Permanent Discontinuations of Sunitinib Treatment at Month 24 Follow-up Visit: mRCC Participants With CR
Complete response retention
|
7 Participants
|
—
|
PRIMARY outcome
Timeframe: Month 24 follow-up study visitPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=9 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Duration of Treatment With Sunitinib Since Complete Remission at Month 24 Follow-up Visit: mRCC Participants With CR
|
7.62 Months
Interval 0.0 to 37.1
|
—
|
PRIMARY outcome
Timeframe: From achieving CR with Sunitinib treatment (before inclusion in the study, participants recruited for 3 years) to Visit at progression (during study); [post inclusion follow-up in the study was maximum of 39.8 months for Cases]Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least Month 24 follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=19 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Time to Progression With Sunitinib Treatment From Complete Remission: mRCC Participants With CR
|
12.65 Months
Interval 2.0 to 51.8
|
—
|
PRIMARY outcome
Timeframe: From complete remission (before inclusion in the study, participants recruited for 3 years) till discontinuation of additional treatment during this study; [post inclusion follow-up in the study was maximum of 39.8 months for Cases]Population: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=11 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Duration of Additional Treatment With Sunitinib Since Complete Remission: mRCC Participants With CR
|
10.0 Months
Interval 2.0 to 49.0
|
—
|
PRIMARY outcome
Timeframe: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for CasesPopulation: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
As per RECIST version 1.1, PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=19 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Types of Progression: mRCC Participants With CR
Local progression
|
1 Participants
|
—
|
|
Number of Participants Categorized According to Types of Progression: mRCC Participants With CR
Distant progression
|
18 Participants
|
—
|
PRIMARY outcome
Timeframe: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for CasesPopulation: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
As per RECIST version 1.1, PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=19 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Site of Progression: mRCC Participants With CR
Known metastatic site · Yes
|
12 Participants
|
—
|
|
Number of Participants Categorized According to Site of Progression: mRCC Participants With CR
Known metastatic site · No
|
7 Participants
|
—
|
|
Number of Participants Categorized According to Site of Progression: mRCC Participants With CR
New metastatic site · Yes
|
12 Participants
|
—
|
|
Number of Participants Categorized According to Site of Progression: mRCC Participants With CR
New metastatic site · No
|
7 Participants
|
—
|
PRIMARY outcome
Timeframe: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for CasesPopulation: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants were categorized according to location of metastases at different body parts (lung, bones, liver, adrenal glands, pancreas, brain, lymph nodes, recurrence at nephrectomy site and other). Participant could have more than 1 location of metastases.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=19 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Location of Metastases: mRCC Participants With CR
Lung
|
7 Participants
|
—
|
|
Number of Participants Categorized According to Location of Metastases: mRCC Participants With CR
Bones
|
4 Participants
|
—
|
|
Number of Participants Categorized According to Location of Metastases: mRCC Participants With CR
Lymph nodes
|
5 Participants
|
—
|
|
Number of Participants Categorized According to Location of Metastases: mRCC Participants With CR
Recurrence at nephrectomy site
|
1 Participants
|
—
|
|
Number of Participants Categorized According to Location of Metastases: mRCC Participants With CR
Liver
|
0 Participants
|
—
|
|
Number of Participants Categorized According to Location of Metastases: mRCC Participants With CR
Adrenal glands
|
1 Participants
|
—
|
|
Number of Participants Categorized According to Location of Metastases: mRCC Participants With CR
Pancreas
|
2 Participants
|
—
|
|
Number of Participants Categorized According to Location of Metastases: mRCC Participants With CR
Brain
|
2 Participants
|
—
|
|
Number of Participants Categorized According to Location of Metastases: mRCC Participants With CR
Other
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for CasesPopulation: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants were categorized according to type of lymph nodes as metastatic site were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=5 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site: mRCC Participants With CR
Supradiaphragmatic · Yes
|
3 Participants
|
—
|
|
Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site: mRCC Participants With CR
Supradiaphragmatic · No
|
2 Participants
|
—
|
|
Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site: mRCC Participants With CR
Infradiaphragmatic · Yes
|
2 Participants
|
—
|
|
Number of Participants Categorized According to Type of Lymph Nodes as Metastatic Site: mRCC Participants With CR
Infradiaphragmatic · No
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Study visit at progression; post inclusion follow-up in the study was maximum of 39.8 months for CasesPopulation: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants were categorized according to number of metastatic sites (1, 2 and 3).
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=19 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Number of Metastatic Sites: mRCC Participants With CR
1
|
14 Participants
|
—
|
|
Number of Participants Categorized According to Number of Metastatic Sites: mRCC Participants With CR
2
|
4 Participants
|
—
|
|
Number of Participants Categorized According to Number of Metastatic Sites: mRCC Participants With CR
3
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: After progression, during follow up period maximum of 39.8 months for CasesPopulation: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants who received systemic treatment after progression were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=19 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Who Received Systemic Treatment After Progression: mRCC Participants With CR
Yes
|
16 Participants
|
—
|
|
Number of Participants Who Received Systemic Treatment After Progression: mRCC Participants With CR
No
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: After progression, during follow up period maximum of 39.8 months for CasesPopulation: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants who received systemic treatment after progression were categorized according to type of treatment. Different types of treatment were tyrosine kinase inhibitor- sunitinib restart, radiotherapy and other systemic treatment. Participant could have more than 1 type of treatment.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=16 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Categorized According to Type of Systemic Treatment Received After Progression: mRCC Participants With CR
Radiotherapy
|
6 Participants
|
—
|
|
Number of Participants Categorized According to Type of Systemic Treatment Received After Progression: mRCC Participants With CR
Other systemic treatment
|
3 Participants
|
—
|
|
Number of Participants Categorized According to Type of Systemic Treatment Received After Progression: mRCC Participants With CR
Tyrosine kinase inhibitor - Sunitinib restart
|
11 Participants
|
—
|
PRIMARY outcome
Timeframe: At the end of study visit follow-up (during follow up period maximum of 39.8 months for Cases)Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least end of study visit follow up. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure with non-missing values. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
Participants with best objective response after progression were evaluated here. It included complete, partial, stabilized and not applicable. PD per RECIST v1.1: at least a 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm. Appearance of one or more new lesions was also considered progression. CR:disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis) \& SD: absence of sufficient reduction for a PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters or absence of a sufficient increase for PD, taking as reference the sum of lowest diameters during study.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=26 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants With Best Objective Response After Progression: mRCC Participants With CR
Complete response
|
7 Participants
|
—
|
|
Number of Participants With Best Objective Response After Progression: mRCC Participants With CR
Partial response
|
1 Participants
|
—
|
|
Number of Participants With Best Objective Response After Progression: mRCC Participants With CR
Stabilized
|
7 Participants
|
—
|
|
Number of Participants With Best Objective Response After Progression: mRCC Participants With CR
Not applicable
|
11 Participants
|
—
|
PRIMARY outcome
Timeframe: Sunitinib initiation (before inclusion, participants recruited for 3 years) till progression (follow up period maximum of 39.8 months for Cases)Population: Analysis population included all eligible participants whose data were observed in the study and who had attended at least end of study visit follow up. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=11 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Duration of Treatment With First Line Sunitinib Till Progression: mRCC Participants With CR
|
24.5 Months
Standard Deviation 29.7
|
—
|
PRIMARY outcome
Timeframe: From inclusion in the study till termination (during follow up period maximum of 39.8 months for Cases)Population: Analysis population included all eligible participants whose data were observed in the study. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
Participants who terminated study early were reported in this outcome measure.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Who Were Early Terminated: mRCC Participants With CR
Yes
|
2 Participants
|
—
|
|
Number of Participants Who Were Early Terminated: mRCC Participants With CR
No
|
33 Participants
|
—
|
PRIMARY outcome
Timeframe: At initiation of sunitinib (during follow up period maximum of 39.8 months for Cases)Population: Data for this outcome measure was not collected, as there were less number of participants who had response.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At initiation of sunitinib (during follow up period maximum of 39.8 months for Cases)Population: Data for this outcome measure was not collected, as there were less number of participants with an event.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At initiation of sunitinib (during follow up period maximum of 39.8 months for Cases)Population: Analysis population included all eligible participants whose data were observed in the study. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
In this outcome measure, participants who died during the study were reported.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Who Died: mRCC Participants With CR
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: At the end of the study (inclusion period was of 3 years and follow up period maximum of 39.8 months for Cases)Population: Analysis population included all eligible participants whose data were observed in the study. This outcome measure was planned to be analyzed only in those participants with mRCC in CR.
PFS was based on Kaplan-Meier estimates. PFS was defined as time in months from start of treatment-to-treatment discontinuation due to disease progression as assessed by the investigator. PD: =\>20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =\>1 new lesions. Disease progression was determined from oncologic assessment data (where data meet the criteria for PD), or from death case report forms (CRFs). This outcome measure was analyzed by using Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Progression Free Survival: mRCC Participants With CR
|
69.4 Months
Interval 32.3 to
Upper limit of 95% CI was not estimable, as there were less than 50% of participants with PFS.
|
—
|
PRIMARY outcome
Timeframe: During follow up period maximum of 39.8 months for Cases and 37 months for ControlsPopulation: Analysis population included all eligible participants whose data were observed in the study and who had attended at least one follow-up visit. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=41 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events
AEs
|
32 Participants
|
41 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
SAEs
|
18 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: During follow up period maximum of 39.8 months for Cases and 37 months for ControlsPopulation: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, possibly considered related to the study treatment. A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=41 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events Possibly Related to Drug Exposure
AEs related to drug exposure
|
15 Participants
|
41 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events Possibly Related to Drug Exposure
SAEs related to drug exposure
|
3 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: During follow up period maximum of 39.8 months for Cases and 37 months for ControlsPopulation: Analysis population included all eligible participants whose data were observed in the study. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Sunitinib: Complete Remission (Cases)
n=32 Participants
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=41 Participants
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Number of AEs According to Action Taken for the Study Treatment in Response to Those AEs
Drug interrupted (temporarily or permanent or dose delayed)
|
16 Adverse events
|
72 Adverse events
|
|
Number of AEs According to Action Taken for the Study Treatment in Response to Those AEs
Dose reduced
|
14 Adverse events
|
118 Adverse events
|
|
Number of AEs According to Action Taken for the Study Treatment in Response to Those AEs
Dose not changed
|
83 Adverse events
|
330 Adverse events
|
|
Number of AEs According to Action Taken for the Study Treatment in Response to Those AEs
Unknown
|
1 Adverse events
|
6 Adverse events
|
|
Number of AEs According to Action Taken for the Study Treatment in Response to Those AEs
Not applicable
|
4 Adverse events
|
9 Adverse events
|
|
Number of AEs According to Action Taken for the Study Treatment in Response to Those AEs
Missing data
|
2 Adverse events
|
6 Adverse events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During follow up period maximum of 39.8 months for Cases and 37 months for ControlsPopulation: Data was not available as the participating centers did not return the biological samples accordingly, to realize the analysis.
Outcome measures
Outcome data not reported
Adverse Events
Sunitinib: Complete Remission (Cases)
Serious events: 18 serious events
Other events: 32 other events
Deaths: 5 deaths
Sunitinib: Non-Complete Remission (Control)
Serious events: 35 serious events
Other events: 40 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 participants at risk
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=41 participants at risk
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Motor dysfunction
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
General physical health deterioration
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
22.0%
9/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Disease evolution
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Asthenia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Malaise
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chest pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Death
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Drug ineffective
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Granuloma
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Mallory-weiss syndrome
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Infection
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Influenza
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Lung infection
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Septic shock
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Balance disorder
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dyskinesia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Epilepsy
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Hemiparesis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Hemiplegia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Pachymeningitis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Seizure
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Angina pectoris
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Coronary artery disease
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood catecholamines abnormal
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight decreased
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Mental disorder
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Breast disorder
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Shock
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Anaphylactic reaction
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Product Issues
Patient-device incompatibility
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Social circumstances
Loss of personal independence in daily activities
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
Sunitinib: Complete Remission (Cases)
n=35 participants at risk
Participants with mRCC in complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
Sunitinib: Non-Complete Remission (Control)
n=41 participants at risk
Participants with mRCC in non-complete remission treated with sunitinib in real world clinical practice as per summary of product characteristics were included in this reporting arm.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Asthenia
|
28.6%
10/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
61.0%
25/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Fatigue
|
22.9%
8/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
48.8%
20/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Mucosal inflammation
|
8.6%
3/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
61.0%
25/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema peripheral
|
8.6%
3/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
22.0%
9/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
26.8%
11/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
General physical health deterioration
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
17.1%
7/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chest pain
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Gait disturbance
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Malaise
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pain
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Face oedema
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Xerosis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chest discomfort
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Hyperthermia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Impaired healing
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Mucosal haemorrhage
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chills
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Feeling hot
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site necrosis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site pain
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site swelling
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Localised oedema
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Mucosal toxicity
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Thirst
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
14/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
78.0%
32/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
11.4%
4/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
58.5%
24/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
5/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
34.1%
14/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
5/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
22.0%
9/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Constipation
|
8.6%
3/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
26.8%
11/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
4/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
17.1%
7/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
19.5%
8/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.6%
3/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
17.1%
7/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.2%
5/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.6%
6/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.2%
5/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dry mouth
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastric disorder
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Stomatitis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Toothache
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gingival recession
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Ileus
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Tooth disorder
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Varicose veins of abdominal wall
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
11.4%
4/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
56.1%
23/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
26.8%
11/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
26.8%
11/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
22.0%
9/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
19.5%
8/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.6%
6/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
8.6%
3/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Erythrosis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.4%
4/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
29.3%
12/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.1%
6/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
22.0%
9/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
17.1%
7/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.6%
3/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue swelling
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dysgeusia
|
11.4%
4/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
34.1%
14/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Sciatica
|
8.6%
3/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.2%
5/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.6%
6/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Nervous system disorder
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Neuralgia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Apraxia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Burning sensation mucosal
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Hemiparesis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Paraparesis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Tremor
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypertension
|
34.3%
12/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
46.3%
19/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypotension
|
8.6%
3/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Haematoma
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hot flush
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Vena cava thrombosis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
7/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
22.0%
9/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
29.3%
12/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.6%
3/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
19.5%
8/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.6%
3/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
19.5%
8/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
17.1%
7/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchitis
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Paronychia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Rhinitis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Lung infection
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchiolitis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Candida infection
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Cystitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Ear infection
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gastroenteritis viral
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Hepatitis e
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Herpes zoster
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Influenza
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Retinitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Sinusitis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Sputum purulent
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Tooth abscess
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.4%
4/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
51.2%
21/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Cell death
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Gout
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Vitamin b complex deficiency
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Vitamin k deficiency
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Weight fluctuation
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.4%
4/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
19.5%
8/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.4%
4/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
17.1%
7/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.6%
3/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Anaemia folate deficiency
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight decreased
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
22.0%
9/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.6%
6/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood pressure abnormal
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood electrolytes abnormal
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Gastrointestinal stoma output increased
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Intestinal transit time decreased
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Oxygen saturation decreased
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Prostatic specific antigen increased
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.2%
5/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Depressed mood
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Depression
|
8.6%
3/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Confusional state
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Sleep disorder
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Affective disorder
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Anger
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Body dysmorphic disorder
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Hypothyroidism
|
17.1%
6/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
22.0%
9/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Hyperthyroidism
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Thyroid mass
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Cushing's syndrome
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Urinary tract disorder
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Dysuria
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal impairment
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Urinary retention
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Orchitis noninfective
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Scrotal inflammation
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Breast disorder
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Breast oedema
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Genital discomfort
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Genital disorder female
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Scrotal erythema
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Eyelid oedema
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.6%
6/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Diplopia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Cataract
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Eye swelling
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Dry eye
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Eye disorder
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Eye pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Ocular discomfort
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Periorbital oedema
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Uveitis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Vision blurred
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Visual impairment
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Injury
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Jaundice
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
17.1%
7/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Ocular icterus
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to kidney
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal cancer
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Tachycardia
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Palpitations
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Vertigo
|
5.7%
2/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Amyloidosis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Sarcoidosis
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
2.9%
1/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Product Issues
Patient-device incompatibility
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.00%
0/35 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • During follow up period maximum of 39.8 months for Cases and 37 months for Controls
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER