Trial Outcomes & Findings for A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone (NCT NCT01544179)
NCT ID: NCT01544179
Last Updated: 2020-09-25
Results Overview
PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
265 participants
Primary outcome timeframe
Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks
Results posted on
2020-09-25
Participant Flow
A total of 265 (100%) patients randomised were from 61 centres in 11 countries: 133 patients to the gefitinib group and132 patients to the placebo group. Patients received maximum of 6 cycles cisplatin plus pemetrexed chemotherapy in addition to the randomised treatment (gefitinib or placebo).
265 patients were randomised. Randomised patients had epidermal growth factor receptor (EGFR) mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and who had progressed on first-line gefitinib treatment
Participant milestones
| Measure |
Gefitinib
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
132
|
|
Overall Study
Received Treatment
|
132
|
132
|
|
Overall Study
Did Not Receive Treatment
|
1
|
0
|
|
Overall Study
COMPLETED
|
70
|
86
|
|
Overall Study
NOT COMPLETED
|
63
|
46
|
Reasons for withdrawal
| Measure |
Gefitinib
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Overall Study
Death
|
50
|
37
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
7
|
|
Overall Study
Eligibility criteria not fulfilled
|
1
|
0
|
Baseline Characteristics
A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone
Baseline characteristics by cohort
| Measure |
Gefitinib
n=133 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=132 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
90 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
188 Participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
43 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
171 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
104 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeksPopulation: Full analysis set (all treated patients)
PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Outcome measures
| Measure |
Gefitinib
n=133 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=132 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Progression-Free Survival (Site Read, Investigator Assessment)
|
98 Patients with a progression event
Interval 4.5 to 5.7
|
107 Patients with a progression event
Interval 4.6 to 5.5
|
PRIMARY outcome
Timeframe: Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeksPopulation: Full analysis set (all treated patients)
PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Outcome measures
| Measure |
Gefitinib
n=133 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=132 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Median Progression-Free Survival (Site Read, Investigator Assessment)
|
5.4 Months
Interval 4.5 to 5.7
|
5.4 Months
Interval 4.6 to 5.5
|
SECONDARY outcome
Timeframe: Following progression survival data was collected every 8 weeks until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurs first.Population: Full analysis set
OS is the time from the date of randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive.
Outcome measures
| Measure |
Gefitinib
n=133 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=132 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Overall Survival (OS)
|
50 Number of patients with an OS event
Interval 10.4 to 19.0
|
37 Number of patients with an OS event
Interval 15.6 to
|
SECONDARY outcome
Timeframe: Baseline and then every 6 weeks after randomization until objective disease progression. OS is then assessed 8 weekly following PFS progression up to PFS analysis data cut off.Population: Full analysis set
Outcome measures
| Measure |
Gefitinib
n=133 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=132 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Median Overall Survival (OS) at Time of PFS Analysis
|
14.8 Months
Interval 10.4 to 19.0
|
17.2 Months
Interval 15.6 to
NA because value was Not Calculated, due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.Population: Full analysis set
ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR.
Outcome measures
| Measure |
Gefitinib
n=133 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=132 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Objective Response Rate (ORR) (Site Read Data)
|
31.6 Percentage of Participants
Interval 0.55 to 1.55
|
34.1 Percentage of Participants
Interval 0.55 to 1.55
|
SECONDARY outcome
Timeframe: Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.Population: Full analysis set
DCR is the percentage of patients who achieve disease control at 6 weeks following randomisation. DCR is defined as a Best Objective Response (BOR) of Complete Response, Partial Response or Stable Disease, as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; SD, neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for Progressive Disease (PD); PD, ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and the sum must have shown an absolute increase of ≥5mm
Outcome measures
| Measure |
Gefitinib
n=133 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=132 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
84.2 Percentage of Participants
Interval 0.74 to 2.62
|
78.8 Percentage of Participants
Interval 0.74 to 2.62
|
SECONDARY outcome
Timeframe: At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.Population: Evaluable-for-QoL
An improvement is defined as a change from baseline of ≥ +6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.
Outcome measures
| Measure |
Gefitinib
n=124 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=129 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Improvement in Trial Outcome Index
|
36 Number of participants improving
Interval 0.74 to 2.62
|
39 Number of participants improving
Interval 0.74 to 2.62
|
SECONDARY outcome
Timeframe: At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.Population: Evaluable-for-QoL
A worsening is defined as a change from baseline of ≤ -6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire
Outcome measures
| Measure |
Gefitinib
n=124 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=129 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Time to Worsening in Trial Outcome Index
|
12.1 Weeks
Interval 8.7 to 18.1
|
9.4 Weeks
Interval 7.7 to 13.4
|
SECONDARY outcome
Timeframe: At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.Population: Evaluable-for-QoL
An improvement is defined as a change from baseline of ≥ +6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire
Outcome measures
| Measure |
Gefitinib
n=124 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=129 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Improvement in FACT-L Total Score
|
44 Number of patients improving
Interval 0.74 to 2.62
|
49 Number of patients improving
Interval 0.74 to 2.62
|
SECONDARY outcome
Timeframe: At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.Population: Evaluable-for-QoL
A worsening is defined as a change from baseline of ≤ -6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire
Outcome measures
| Measure |
Gefitinib
n=124 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=129 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Time to Worsening in FACT-L Total Score
|
12.0 Weeks
Interval 6.0 to 15.0
|
8.9 Weeks
Interval 6.0 to 9.9
|
SECONDARY outcome
Timeframe: At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.Population: Evaluable-for-QoL
An improvement is defined as a change from baseline of ≥ +2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire
Outcome measures
| Measure |
Gefitinib
n=124 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=129 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Improvement in Lung Cancer Subscale
|
54 Number of participants improving
|
55 Number of participants improving
|
SECONDARY outcome
Timeframe: At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.Population: Evaluable-for-QoL
A worsening is defined as a change from baseline of ≤ -2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire
Outcome measures
| Measure |
Gefitinib
n=124 Participants
Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
|
Placebo
n=129 Participants
Placebo and cisplatin plus pemetrexed combination chemotherapy.
|
|---|---|---|
|
Time to Worsening in Lung Cancer Subscale
|
14.6 Weeks
Interval 9.1 to 24.3
|
9.1 Weeks
Interval 6.1 to 23.9
|
Adverse Events
Gefitinib 250 mg
Serious events: 38 serious events
Other events: 125 other events
Deaths: 0 deaths
Placebo
Serious events: 28 serious events
Other events: 129 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gefitinib 250 mg
n=132 participants at risk
|
Placebo
n=132 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Pericardial effusion
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Dysphagia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Nausea
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Vomiting
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Multi-organ failure
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Pyrexia
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Anal abscess
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Bronchitis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Cellulitis
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Lung infection
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Paronychia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Pneumonia
|
3.0%
4/132 • Number of events 5 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Urinary tract infection
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Injury, poisoning and procedural complications
Fall
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Aphasia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Cerebrovascular accident
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Cognitive disorder
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Epilepsy
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Headache
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Loss of consciousness
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Seizure
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Psychiatric disorders
Delirium
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Acute kidney injury
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Circulatory collapse
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Embolism
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Orthostatic hypotension
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Vena cava thrombosis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Venous thrombosis limb
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
Other adverse events
| Measure |
Gefitinib 250 mg
n=132 participants at risk
|
Placebo
n=132 participants at risk
|
|---|---|---|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Paraesthesia
|
3.8%
5/132 • Number of events 6 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
5.3%
7/132 • Number of events 8 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.8%
9/132 • Number of events 12 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
7.6%
10/132 • Number of events 12 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Petit mal epilepsy
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Anaemia
|
30.3%
40/132 • Number of events 56 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
24.2%
32/132 • Number of events 40 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
3.0%
4/132 • Number of events 7 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
6.1%
8/132 • Number of events 21 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Erythropenia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
2.3%
3/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
2.3%
3/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.5%
27/132 • Number of events 61 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
16.7%
22/132 • Number of events 53 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.76%
1/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.0%
29/132 • Number of events 59 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
21.2%
28/132 • Number of events 69 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
7/132 • Number of events 11 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
6.8%
9/132 • Number of events 11 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Cardiac failure
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Myocardial ischaemia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Nodal arrhythmia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Palpitations
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.8%
5/132 • Number of events 5 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Congenital, familial and genetic disorders
Ichthyosis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Ear and labyrinth disorders
Ototoxicity
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Ear and labyrinth disorders
Tinnitus
|
4.5%
6/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.0%
4/132 • Number of events 6 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Ear and labyrinth disorders
Vertigo
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Blepharitis
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Cataract
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Diplopia
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Dry eye
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Eczema eyelids
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Eye discharge
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Eye pain
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Keratitis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Lacrimation increased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Trichiasis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Visual impairment
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Abdominal distension
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
2.3%
3/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
7/132 • Number of events 7 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
12/132 • Number of events 16 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
9.8%
13/132 • Number of events 16 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Cheilitis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Constipation
|
25.8%
34/132 • Number of events 58 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
26.5%
35/132 • Number of events 56 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Diarrhoea
|
32.6%
43/132 • Number of events 71 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
14.4%
19/132 • Number of events 22 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
3/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.8%
5/132 • Number of events 6 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Dysphagia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Enteritis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.5%
2/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Flatulence
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.8%
5/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.8%
5/132 • Number of events 10 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Haematemesis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
3.0%
4/132 • Number of events 6 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.5%
2/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Nausea
|
63.6%
84/132 • Number of events 180 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
60.6%
80/132 • Number of events 160 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Oral disorder
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Stomatitis
|
10.6%
14/132 • Number of events 15 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.8%
5/132 • Number of events 8 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Gastrointestinal disorders
Vomiting
|
40.9%
54/132 • Number of events 96 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
32.6%
43/132 • Number of events 75 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Asthenia
|
11.4%
15/132 • Number of events 27 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
22.7%
30/132 • Number of events 43 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Chest pain
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Chills
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Face oedema
|
3.8%
5/132 • Number of events 5 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Fatigue
|
21.2%
28/132 • Number of events 37 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
17.4%
23/132 • Number of events 31 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
General physical health deterioration
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Generalised oedema
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Influenza like illness
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Local swelling
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Malaise
|
7.6%
10/132 • Number of events 10 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
6.8%
9/132 • Number of events 15 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Mucosal inflammation
|
4.5%
6/132 • Number of events 8 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
2.3%
3/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Nodule
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Oedema
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Oedema peripheral
|
3.8%
5/132 • Number of events 6 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.0%
4/132 • Number of events 5 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Pain
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Performance status decreased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Pyrexia
|
15.9%
21/132 • Number of events 24 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
10.6%
14/132 • Number of events 15 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Sensation of foreign body
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
General disorders
Sense of oppression
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Bronchitis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Candida infection
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Clostridium difficile colitis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Conjunctivitis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
6.1%
8/132 • Number of events 8 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Cystitis
|
4.5%
6/132 • Number of events 6 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Folliculitis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Gastroenteritis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Herpes simplex
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Influenza
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Localised infection
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Lung infection
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
5/132 • Number of events 7 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
6.1%
8/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Oral herpes
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Paronychia
|
4.5%
6/132 • Number of events 6 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Parotitis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Pharyngitis
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Pneumonia
|
1.5%
2/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Pyelonephritis acute
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Respiratory tract infection
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Sinusitis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Skin infection
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
5/132 • Number of events 5 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.8%
5/132 • Number of events 5 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Urinary tract infection
|
4.5%
6/132 • Number of events 8 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Vaginal infection
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Injury, poisoning and procedural complications
Contusion
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Alanine aminotransferase decreased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
5/132 • Number of events 5 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
8.3%
11/132 • Number of events 17 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Albumin globulin ratio abnormal
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Aspartate aminotransferase decreased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
8/132 • Number of events 10 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
7.6%
10/132 • Number of events 16 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Blood albumin decreased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Blood alkaline phosphatase increased
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Blood bilirubin decreased
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Blood creatinine increased
|
9.1%
12/132 • Number of events 14 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
9.1%
12/132 • Number of events 17 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Blood potassium decreased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Blood pressure increased
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Blood sodium decreased
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Blood urea increased
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.0%
4/132 • Number of events 10 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Blood uric acid increased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Breath sounds abnormal
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
C-reactive protein increased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Computerised tomogram thorax abnormal
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Haemoglobin decreased
|
6.1%
8/132 • Number of events 10 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.0%
4/132 • Number of events 5 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Lymphocyte count decreased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Neutrophil count decreased
|
12.1%
16/132 • Number of events 31 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
16.7%
22/132 • Number of events 47 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Occult blood
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Occult blood positive
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Palpatory finding abnormal
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Platelet count decreased
|
6.8%
9/132 • Number of events 15 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
2.3%
3/132 • Number of events 6 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Protein total decreased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Protein urine
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Protein urine present
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Total bile acids increased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Transaminases increased
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Weight decreased
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.8%
5/132 • Number of events 8 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
Weight increased
|
2.3%
3/132 • Number of events 8 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
White blood cell count decreased
|
12.9%
17/132 • Number of events 38 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
9.8%
13/132 • Number of events 24 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Investigations
White blood cells urine positive
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Decreased appetite
|
48.5%
64/132 • Number of events 92 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
34.1%
45/132 • Number of events 74 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.0%
4/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 5 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.5%
2/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.1%
8/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.8%
13/132 • Number of events 21 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.8%
5/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.5%
6/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
11/132 • Number of events 17 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
4.5%
6/132 • Number of events 8 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
2.3%
3/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
8/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
5.3%
7/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
11/132 • Number of events 11 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
10.6%
14/132 • Number of events 15 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.5%
6/132 • Number of events 6 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.8%
5/132 • Number of events 5 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.8%
5/132 • Number of events 5 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.1%
8/132 • Number of events 10 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
6.8%
9/132 • Number of events 15 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Aphasia
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Aphonia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Brain injury
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Cerebral ischaemia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Clonic convulsion
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Dizziness
|
6.8%
9/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
4.5%
6/132 • Number of events 6 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Dysaesthesia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Dysgeusia
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
5.3%
7/132 • Number of events 10 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Headache
|
8.3%
11/132 • Number of events 14 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
13.6%
18/132 • Number of events 24 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Hypoaesthesia
|
3.8%
5/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Lethargy
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Mental retardation
|
1.5%
2/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
2.3%
3/132 • Number of events 8 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Migraine
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Monoplegia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.76%
1/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Neuropathy peripheral
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Poor quality sleep
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Presyncope
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Seizure
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Somnolence
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Tremor
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Nervous system disorders
Vocal cord paralysis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Psychiatric disorders
Agitation
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Psychiatric disorders
Anxiety
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
2.3%
3/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Psychiatric disorders
Confusional state
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Psychiatric disorders
Delirium
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Psychiatric disorders
Depression
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Psychiatric disorders
Insomnia
|
7.6%
10/132 • Number of events 12 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
5.3%
7/132 • Number of events 7 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Psychiatric disorders
Nervousness
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Acute kidney injury
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Dysuria
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Haematuria
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Proteinuria
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Renal disorder
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Renal impairment
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Renal injury
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Urethral pain
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Urinary incontinence
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Renal and urinary disorders
Urinary retention
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Reproductive system and breast disorders
Breast mass
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Reproductive system and breast disorders
Cystocele
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Reproductive system and breast disorders
Genital paraesthesia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Reproductive system and breast disorders
Oedema genital
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Reproductive system and breast disorders
Prostatitis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
20/132 • Number of events 23 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
11.4%
15/132 • Number of events 18 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
12/132 • Number of events 13 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
6.8%
9/132 • Number of events 10 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.3%
7/132 • Number of events 11 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
5.3%
7/132 • Number of events 10 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.6%
10/132 • Number of events 10 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
7.6%
10/132 • Number of events 11 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.5%
6/132 • Number of events 6 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.8%
9/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.8%
5/132 • Number of events 5 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.1%
8/132 • Number of events 11 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
3.0%
4/132 • Number of events 4 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.1%
12/132 • Number of events 12 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
6.1%
8/132 • Number of events 8 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.1%
8/132 • Number of events 9 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
5.3%
7/132 • Number of events 8 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.4%
15/132 • Number of events 20 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
8.3%
11/132 • Number of events 12 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Trichorrhexis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Deep vein thrombosis
|
2.3%
3/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
1.5%
2/132 • Number of events 2 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Embolism
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Erythromelalgia
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Flushing
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Hypertension
|
1.5%
2/132 • Number of events 3 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
4.5%
6/132 • Number of events 6 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Hypotension
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
|
Vascular disorders
Thrombosis
|
0.76%
1/132 • Number of events 1 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
0.00%
0/132 • AEs were collected from signature of informed consent, throughout the treatment period until 30 days after discontinuation of the investigational product
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60