Trial Outcomes & Findings for Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults (NCT NCT03605212)
NCT ID: NCT03605212
Last Updated: 2021-06-03
Results Overview
Apparent clearance of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
7 days
Results posted on
2021-06-03
Participant Flow
The first patient was screened and enrolled on 27 Feb 2017. The last patient completed the study on 16 Jul 2018. The study was conducted at 17 sites in 4 European countries.
A total of 31 patients was screened, of whom 30 were enrolled and 28 completed the study regularly. Two enrolled patients were withdrawn from study drug treatment.
Participant milestones
| Measure |
Cohort 1
Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 2
Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 3
Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 4
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Adults
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
|---|---|---|---|---|---|
|
Baseline Period
STARTED
|
3
|
0
|
3
|
0
|
24
|
|
Baseline Period
COMPLETED
|
3
|
0
|
3
|
0
|
24
|
|
Baseline Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
STARTED
|
3
|
0
|
3
|
0
|
24
|
|
Treatment Period
COMPLETED
|
2
|
0
|
3
|
0
|
23
|
|
Treatment Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 2
Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 3
Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 4
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Adults
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
|---|---|---|---|---|---|
|
Treatment Period
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 2
Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 3
n=3 Participants
Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 4
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Adults
n=24 Participants
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
|
Age, Continuous
|
7.33 years
STANDARD_DEVIATION 1.528 • n=99 Participants
|
—
|
14.00 years
STANDARD_DEVIATION 1.000 • n=206 Participants
|
—
|
60.21 years
STANDARD_DEVIATION 15.376 • n=31 Participants
|
50.30 years
STANDARD_DEVIATION 24.419 • n=30 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
29 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
28 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Region of Enrollment
Hungary
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
—
|
8 participants
n=31 Participants
|
8 participants
n=30 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=99 Participants
|
—
|
3 participants
n=206 Participants
|
—
|
5 participants
n=31 Participants
|
11 participants
n=30 Participants
|
|
Region of Enrollment
Bulgaria
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
—
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
—
|
11 participants
n=31 Participants
|
11 participants
n=30 Participants
|
|
Weight
|
26.13 kg
STANDARD_DEVIATION 2.043 • n=99 Participants
|
—
|
60.47 kg
STANDARD_DEVIATION 19.747 • n=206 Participants
|
—
|
75.60 kg
STANDARD_DEVIATION 15.469 • n=31 Participants
|
68.92 kg
STANDARD_DEVIATION 21.369 • n=30 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Data were not collected.
Apparent clearance of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 daysPopulation: Data were not collected.
Apparent volume of distribution of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 daysPopulation: Data were not collected.
Absorption rate constant of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 daysPopulation: Data were not collected.
AUC of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 daysPopulation: Data were not collected.
Maximum plasma concentration of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 daysPopulation: Data were not collected.
Time to Cmax from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 daysPopulation: Data were not collected.
Area under the curve of sUA from baseline (Visit 1, Day 1) to the Evaluation Visit (Visit 8, Day 8) (AUC sUA 1-8)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysPopulation: Data were not collected.
Assessment of LTLS at Visit 1 (Day 1) and from Start of Chemotherapy (Visit 3, Day 3) to the Evaluation Visit (Visit 8, Day 8). LTLS is diagnosed if levels of 2 or more values of uric acid, potassium, phosphate or calcium are more than or less than normal at presentation or if they change by at least 25% from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysPopulation: Data were not collected.
Assessment of CTLS at Visit 1 (Day 1) and from Start of Chemotherapy (Visit 3, Day 3) to the Evaluation Visit (Visit 8, Day 8). CTLS is present when LTLS is accompanied by at least one of the following significant clinical complications: increased creatinine level ≥ 1.5 upper limit of normal, cardiac arrhythmia/sudden death or seizure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Estimated maximum time frame: 27 daysPopulation: Safety population
Assessment of incidence, severity (through Mild/Moderate/Severe scale), seriousness and treatment-causality of TESS from Screening Visit to End of Study Visit. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. An adverse event was considered as TESS if it occured for the first time or if it worsened in terms of seriousness or severity after first study drug intake.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 2
Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 3
n=3 Participants
Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 4
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Adults
n=24 Participants
Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
|---|---|---|---|---|---|
|
Assessment of Treatment Emergent Signs and Symptoms (TESS)
TESS
|
50 Events
|
—
|
21 Events
|
—
|
70 Events
|
|
Assessment of Treatment Emergent Signs and Symptoms (TESS)
TESS grade >/=3
|
11 Events
|
—
|
2 Events
|
—
|
20 Events
|
|
Assessment of Treatment Emergent Signs and Symptoms (TESS)
Serious TESS
|
1 Events
|
—
|
0 Events
|
—
|
7 Events
|
|
Assessment of Treatment Emergent Signs and Symptoms (TESS)
Related TESS
|
4 Events
|
—
|
0 Events
|
—
|
0 Events
|
|
Assessment of Treatment Emergent Signs and Symptoms (TESS)
Related TESS grade >/=3
|
2 Events
|
—
|
0 Events
|
—
|
0 Events
|
|
Assessment of Treatment Emergent Signs and Symptoms (TESS)
Related TESS/Drug Withdrawn
|
2 Events
|
—
|
0 Events
|
—
|
0 Events
|
SECONDARY outcome
Timeframe: Estimated maximum time frame: 27 daysPopulation: Safety population
Number of participants affected by TESS from Screening Visit to End of Study Visit.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 2
Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 3
n=3 Participants
Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 4
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Adults
n=24 Participants
Febuxostat film-coated tablets 120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
|---|---|---|---|---|---|
|
Assessment of Participants Affected by Treatment Emergent Signs and Symptoms (TESS)
|
3 participants
|
—
|
3 participants
|
—
|
20 participants
|
SECONDARY outcome
Timeframe: Estimated maximum time frame: 27 daysPopulation: Data were not collected.
Quality of life was to be assessed by PS evaluation from Screening Visit to End of Study Visit. The Karnofsky Performance Status (KPS) scale was to be used for patients aged 16 years and older; the Lansky Play Performance Status (LPS) scale was to be used for patients aged less than 16 years. Both scales range from scores of 0 to 100 points at intervals of 10 where 0 points represent the worst outcome (KPS: 0 = death; LPS: 0 = unresponsive) and 100 points the best (KPS: 100 = normal, no complaints, no evidence of disease; LPS: 100 = fully active).
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adults
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 2
Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 3
n=3 participants at risk
Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 4
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Adults
n=24 participants at risk
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
|---|---|---|---|---|---|
|
Investigations
Enterobacter test positiv
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Infections and infestations
Septioc shock
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
Febuxostat film-coated tablets 2x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 2
Febuxostat film-coated tablets 3x20 mg/QD for 7-9 days
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 3
n=3 participants at risk
Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Cohort 4
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
Adults
n=24 participants at risk
Febuxostat film-coated tablets 1x120 mg/QD for 7-9 days (Adenuric® 120 mg)
Febuxostat: Intervention is orally administered to patients in this arm.
|
|---|---|---|---|---|---|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
General disorders
Asthenia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
General disorders
Facial pain
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
General disorders
Inflammation
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
12.5%
3/24 • Number of events 3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Investigations
ALT increased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Investigations
AST increased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Investigations
BP increased
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Investigations
Blood triglycerides increased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Investigations
Gamma-glutamyltransferase
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Investigations
Hemoglobin decreased
|
33.3%
1/3 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Investigations
White blood cell (WBC) count decreased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Cardiac disorders
Arrhythmia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
16.7%
4/24 • Number of events 4 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
12.5%
3/24 • Number of events 3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
66.7%
2/3 • Number of events 3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
16.7%
4/24 • Number of events 4 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Nervous system disorders
Language disorder
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
16.7%
4/24 • Number of events 4 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
100.0%
3/3 • Number of events 3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
16.7%
4/24 • Number of events 5 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
16.7%
4/24 • Number of events 5 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Faeces soft
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Gingival swelling
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Hematemesis
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Hematochezia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 4 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Musculoskeletal and connective tissue disorders
Muscoskeletal pain
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Metabolism and nutrition disorders
Hypo HDL cholesterolaemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
—
0/0 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
0.00%
0/24 • Adverse events were collected over the entire duration of a patient's study participation, i.e. approximately 3 weeks. In addition, if after the end of the study the Investigator became aware of any AEs or follow-up in AEs already recorded, this information could be recorded in the eCRF until it was available.
Adverse Events were collected during Screening, i.e. after ICF signature until DAY 1, Visit 1 before first IMP intake and specifically Treatment Emergent Signs and Symptoms (TESSs) occurring from first IMP intake at Visit 1, DAY 1 until Visit 10, DAY 14.
|
Additional Information
Angela Capriati, MD PhD - Corporate Director Clinical Sciences
Menarini Group
Phone: +39 055 5680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submitting the results of this study for publication or presentation, the Investigator will allow the sponsor at least 60 days time to review and comment upon the publication manuscript. It is agreed, that the results of the study will not be submitted for presentation, abstract, poster exhibition, or publication by the investigator until the sponsor has reviewed/commented and agreed to any publication.
- Publication restrictions are in place
Restriction type: OTHER