Trial Outcomes & Findings for A Phase I Dose-escalation Study of Subcutaneous ALM201 in Patients With Advanced Ovarian Cancer and Other Solid Tumours (NCT NCT03427073)
NCT ID: NCT03427073
Last Updated: 2019-09-11
Results Overview
All events and suspected dose limiting toxicities (DLTs) were graded according to the CTCAE, version 4.03. A DLT was defined as a Grade 3 or 4 AE that, in the opinion of the CRC, was likely to be related to ALM201 and represented a clinically significant hazard to the patient. Qualifying DLT events were considered to be clinically relevant; e.g. in duration, apparent reversibility, required management, and upon consideration of the patient's medical history and/or concomitant medications. DLT events were also evaluated in terms of what was considered to be an appropriate next escalation step: In the case where the CRC agreed that an escalation step of approximately 33% or lower was merited; the toxicity of concern could be declared a DLT. In order to be evaluable for DLT assessment, a patient had to receive at least 80% of their scheduled doses (e.g. 12 of the 15), unless this lack of compliance was due to ALM201-related toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Adverse event evaluation was done during treatment and follow-up. DLT evaluation was done during cycle 1
Results posted on
2019-09-11
Participant Flow
Recruitment was carried out in three study sites in Belfast, Manchester and Newcastle, UK starting on 27 April 2015.
Part 1 enrolled adult patients with advanced solid tumours in whom treatment with an anti-angiogenic agent was appropriate. Participants had screening evaluations between Day -1 and -28 before entering the first 21-day treatment cycle.
Participant milestones
| Measure |
Cohort 1 - ALM201
One patient received 10 mg IMP from cycle 1 through cycle 6.
|
Cohort 2 - ALM201
One patient received 20 mg IMP in cycle 1 and cycle 2.
|
Cohort 3 - ALM201
One patient received 40 mg IMP from cycle 1 through cycle 3.
|
Cohort 4 - ALM201
Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
|
Cohort 5 - ALM201
Three patients received 160 mg of IMP in cycles 1 and 2.
|
Cohort 6 - ALM201
Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
|
Cohort 7 - ALM201
Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
|
Cohort 8 - ALM201
Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
3
|
3
|
4
|
3
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
3
|
3
|
4
|
3
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1 - ALM201
One patient received 10 mg IMP from cycle 1 through cycle 6.
|
Cohort 2 - ALM201
One patient received 20 mg IMP in cycle 1 and cycle 2.
|
Cohort 3 - ALM201
One patient received 40 mg IMP from cycle 1 through cycle 3.
|
Cohort 4 - ALM201
Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
|
Cohort 5 - ALM201
Three patients received 160 mg of IMP in cycles 1 and 2.
|
Cohort 6 - ALM201
Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
|
Cohort 7 - ALM201
Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
|
Cohort 8 - ALM201
Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease Progression
|
1
|
1
|
1
|
3
|
3
|
4
|
2
|
3
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Phase I Dose-escalation Study of Subcutaneous ALM201 in Patients With Advanced Ovarian Cancer and Other Solid Tumours
Baseline characteristics by cohort
| Measure |
Cohort 1 - ALM201
n=1 Participants
One patient received 10 mg IMP from cycle 1 through cycle 6.
|
Cohort 2 - ALM201
n=1 Participants
One patient received 20 mg IMP in cycle 1 and cycle 2.
|
Cohort 3 - ALM201
n=1 Participants
One patient received 40 mg IMP from cycle 1 through cycle 3.
|
Cohort 4 - ALM201
n=3 Participants
Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
|
Cohort 5 - ALM201
n=3 Participants
Three patients received 160 mg of IMP in cycles 1 and 2.
|
Cohort 6 - ALM201
n=4 Participants
Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
|
Cohort 7 - ALM201
n=3 Participants
Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
|
Cohort 8 - ALM201
n=4 Participants
Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
14 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
12 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=114 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
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 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
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 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
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 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
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
20 Participants
n=114 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
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (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
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Adverse event evaluation was done during treatment and follow-up. DLT evaluation was done during cycle 1Population: Reporting group
All events and suspected dose limiting toxicities (DLTs) were graded according to the CTCAE, version 4.03. A DLT was defined as a Grade 3 or 4 AE that, in the opinion of the CRC, was likely to be related to ALM201 and represented a clinically significant hazard to the patient. Qualifying DLT events were considered to be clinically relevant; e.g. in duration, apparent reversibility, required management, and upon consideration of the patient's medical history and/or concomitant medications. DLT events were also evaluated in terms of what was considered to be an appropriate next escalation step: In the case where the CRC agreed that an escalation step of approximately 33% or lower was merited; the toxicity of concern could be declared a DLT. In order to be evaluable for DLT assessment, a patient had to receive at least 80% of their scheduled doses (e.g. 12 of the 15), unless this lack of compliance was due to ALM201-related toxicity.
Outcome measures
| Measure |
Cohort 1 - ALM201
n=1 Participants
One patient received 10 mg IMP from cycle 1 through cycle 6.
|
Cohort 2 - ALM201
n=1 Participants
One patient received 20 mg IMP in cycle 1 and cycle 2.
|
Cohort 3 - ALM201
n=1 Participants
One patient received 40 mg IMP from cycle 1 through cycle 3.
|
Cohort 4 - ALM201
n=3 Participants
Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
|
Cohort 5 - ALM201
n=3 Participants
Three patients received 160 mg of IMP in cycles 1 and 2.
|
Cohort 6 - ALM201
n=4 Participants
Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
|
Cohort 7 - ALM201
n=3 Participants
Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
|
Cohort 8 - ALM201
n=4 Participants
Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability - Evaluation of AEs and DLT
TEAE treatment related
|
1 participants
|
0 participants
|
1 participants
|
3 participants
|
3 participants
|
4 participants
|
3 participants
|
4 participants
|
|
Safety and Tolerability - Evaluation of AEs and DLT
TEAE DLT
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
3 participants
|
4 participants
|
3 participants
|
2 participants
|
|
Safety and Tolerability - Evaluation of AEs and DLT
SAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability - Evaluation of AEs and DLT
treatment related SAE
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Response assessments were done to assess clinical benefit in the efficacy population overall and at the end of cycles 2, 4 and 6, as applicablePopulation: Reporting group
As this was a Phase 1 study, the extent of efficacy data was expected to be limited. Using RECIST Version 1.1, a summary of clinical benefit from patients with evaluable disease was generated via CT scans: Complete Response (CR) = Disappearance of all target \& non-target lesions + normalization of tumor marker; Partial Response (PR) ≥ 30% decrease in the sum of LD of target lesions; Progressive Disease (PD) ≥ 20% increase (\& 5mm absolute increase) in sum of LD of target lesions or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
Cohort 1 - ALM201
n=1 Participants
One patient received 10 mg IMP from cycle 1 through cycle 6.
|
Cohort 2 - ALM201
n=1 Participants
One patient received 20 mg IMP in cycle 1 and cycle 2.
|
Cohort 3 - ALM201
n=1 Participants
One patient received 40 mg IMP from cycle 1 through cycle 3.
|
Cohort 4 - ALM201
n=3 Participants
Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
|
Cohort 5 - ALM201
n=3 Participants
Three patients received 160 mg of IMP in cycles 1 and 2.
|
Cohort 6 - ALM201
n=4 Participants
Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
|
Cohort 7 - ALM201
n=3 Participants
Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
|
Cohort 8 - ALM201
n=4 Participants
Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
|
|---|---|---|---|---|---|---|---|---|
|
Tumour Response Assessment - Best Overall Response
Stable Disease (SD)
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
1 participants
|
|
Tumour Response Assessment - Best Overall Response
Complete Response (CR)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Tumour Response Assessment - Best Overall Response
Partial Response (PR)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Tumour Response Assessment - Best Overall Response
Overall Response Rate (CR+PR)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Tumour Response Assessment - Best Overall Response
Disease Control Rate (CR+PR+SD)
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
1 participants
|
|
Tumour Response Assessment - Best Overall Response
Progressive Disease
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
3 participants
|
1 participants
|
1 participants
|
3 participants
|
|
Tumour Response Assessment - Best Overall Response
Not Evaluable (NE+NA)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Tmax was determined in cycles 1, 2, 4 and 6 of treatmentPopulation: Reporting group
Tmax was derived from the individual patient plasma concentration versus time profiles of ALM201.
Outcome measures
| Measure |
Cohort 1 - ALM201
n=1 Participants
One patient received 10 mg IMP from cycle 1 through cycle 6.
|
Cohort 2 - ALM201
n=1 Participants
One patient received 20 mg IMP in cycle 1 and cycle 2.
|
Cohort 3 - ALM201
n=1 Participants
One patient received 40 mg IMP from cycle 1 through cycle 3.
|
Cohort 4 - ALM201
n=3 Participants
Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
|
Cohort 5 - ALM201
n=3 Participants
Three patients received 160 mg of IMP in cycles 1 and 2.
|
Cohort 6 - ALM201
n=4 Participants
Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
|
Cohort 7 - ALM201
n=3 Participants
Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
|
Cohort 8 - ALM201
n=4 Participants
Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Tmax
Cycle 1 - Day 1
|
1.45 hour
Interval 1.45 to 1.45
|
1.50 hour
Interval 1.5 to 1.5
|
1.63 hour
Interval 1.63 to 1.63
|
1.53 hour
Interval 0.75 to 2.0
|
1.52 hour
Interval 0.8 to 3.07
|
2.50 hour
Interval 1.5 to 3.08
|
2.00 hour
Interval 0.75 to 4.0
|
1.50 hour
Interval 1.3 to 1.5
|
|
Pharmacokinetics: Tmax
Cycle 1 - Day 3
|
0.50 hour
Interval 0.5 to 0.5
|
1.00 hour
Interval 1.0 to 1.0
|
1.50 hour
Interval 1.5 to 1.5
|
1.50 hour
Interval 1.05 to 2.0
|
1.52 hour
Interval 1.52 to 2.05
|
2.00 hour
Interval 1.48 to 2.0
|
1.02 hour
Interval 1.0 to 2.0
|
1.61 hour
Interval 0.5 to 2.02
|
|
Pharmacokinetics: Tmax
Cycle 1 - Day 18
|
1.58 hour
Interval 1.58 to 1.58
|
1.02 hour
Interval 1.02 to 1.02
|
1.00 hour
Interval 1.0 to 1.0
|
1.23 hour
Interval 0.47 to 2.0
|
1.50 hour
Interval 0.5 to 2.0
|
2.03 hour
Interval 1.0 to 3.5
|
1.50 hour
Interval 1.0 to 2.07
|
1.90 hour
Interval 1.45 to 2.35
|
|
Pharmacokinetics: Tmax
Cycle 2 - Day 18
|
2.00 hour
Interval 2.0 to 2.0
|
1.00 hour
Interval 1.0 to 1.0
|
1.03 hour
Interval 1.03 to 1.03
|
3.50 hour
Interval 3.5 to 3.5
|
2.00 hour
Interval 2.0 to 2.0
|
1.54 hour
Interval 1.5 to 1.58
|
2.00 hour
Interval 1.48 to 2.13
|
1.02 hour
Interval 1.02 to 1.02
|
|
Pharmacokinetics: Tmax
Cycle 4 - Day 18
|
1.53 hour
Interval 1.53 to 1.53
|
—
|
—
|
—
|
—
|
1.57 hour
Interval 1.0 to 2.13
|
1.12 hour
Interval 1.12 to 1.12
|
—
|
|
Pharmacokinetics: Tmax
Cycle 6 - Day 18
|
1.85 hour
Interval 1.85 to 1.85
|
—
|
—
|
—
|
—
|
—
|
2.02 hour
Interval 2.02 to 2.02
|
—
|
SECONDARY outcome
Timeframe: AUC 0-t was determined in cycles 1, 2, 4 and 6 of treatmentPopulation: Reporting group
AUC 0-t was derived from the individual patient plasma concentration versus time profiles of ALM201.
Outcome measures
| Measure |
Cohort 1 - ALM201
n=1 Participants
One patient received 10 mg IMP from cycle 1 through cycle 6.
|
Cohort 2 - ALM201
n=1 Participants
One patient received 20 mg IMP in cycle 1 and cycle 2.
|
Cohort 3 - ALM201
n=1 Participants
One patient received 40 mg IMP from cycle 1 through cycle 3.
|
Cohort 4 - ALM201
n=3 Participants
Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
|
Cohort 5 - ALM201
n=3 Participants
Three patients received 160 mg of IMP in cycles 1 and 2.
|
Cohort 6 - ALM201
n=4 Participants
Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
|
Cohort 7 - ALM201
n=3 Participants
Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
|
Cohort 8 - ALM201
n=4 Participants
Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: AUC 0-t
Cycle 1 - Day 1
|
485 ng*h/mL
Interval 485.0 to 485.0
|
1040 ng*h/mL
Interval 1040.0 to 1040.0
|
1920 ng*h/mL
Interval 1920.0 to 1920.0
|
3380 ng*h/mL
Interval 3100.0 to 3790.0
|
6510 ng*h/mL
Interval 5600.0 to 7560.0
|
5860 ng*h/mL
Interval 3460.0 to 10200.0
|
11900 ng*h/mL
Interval 9470.0 to 15100.0
|
6280 ng*h/mL
Interval 1140.0 to 14800.0
|
|
Pharmacokinetics: AUC 0-t
Cycle 1 - Day 3
|
868 ng*h/mL
Interval 868.0 to 868.0
|
1160 ng*h/mL
Interval 1160.0 to 1160.0
|
898 ng*h/mL
Interval 898.0 to 898.0
|
2970 ng*h/mL
Interval 2660.0 to 3430.0
|
5100 ng*h/mL
Interval 4970.0 to 5280.0
|
6630 ng*h/mL
Interval 4460.0 to 11900.0
|
12500 ng*h/mL
Interval 10500.0 to 14700.0
|
8870 ng*h/mL
Interval 5380.0 to 12800.0
|
|
Pharmacokinetics: AUC 0-t
Cycle 1 - Day 18
|
817 ng*h/mL
Interval 817.0 to 817.0
|
718 ng*h/mL
Interval 718.0 to 718.0
|
1840 ng*h/mL
Interval 1840.0 to 1840.0
|
3500 ng*h/mL
Interval 3440.0 to 3570.0
|
4930 ng*h/mL
Interval 4400.0 to 5400.0
|
5570 ng*h/mL
Interval 3900.0 to 10000.0
|
12100 ng*h/mL
Interval 11400.0 to 12900.0
|
8100 ng*h/mL
Interval 7000.0 to 9370.0
|
|
Pharmacokinetics: AUC 0-t
Cycle 2 - Day 18
|
702 ng*h/mL
Interval 702.0 to 702.0
|
1020 ng*h/mL
Interval 1020.0 to 1020.0
|
1950 ng*h/mL
Interval 1950.0 to 1950.0
|
3230 ng*h/mL
Interval 3230.0 to 3230.0
|
5710 ng*h/mL
Interval 5710.0 to 5710.0
|
5680 ng*h/mL
Interval 3810.0 to 8480.0
|
10400 ng*h/mL
Interval 7290.0 to 16700.0
|
5930 ng*h/mL
Interval 5930.0 to 5930.0
|
|
Pharmacokinetics: AUC 0-t
Cycle 4 - Day 18
|
476 ng*h/mL
Interval 476.0 to 476.0
|
—
|
—
|
—
|
—
|
6110 ng*h/mL
Interval 4150.0 to 9010.0
|
8600 ng*h/mL
Interval 8600.0 to 8600.0
|
—
|
|
Pharmacokinetics: AUC 0-t
Cycle 6 - Day 18
|
1040 ng*h/mL
Interval 1040.0 to 1040.0
|
—
|
—
|
—
|
—
|
—
|
26700 ng*h/mL
Interval 26700.0 to 26700.0
|
—
|
SECONDARY outcome
Timeframe: Cmax of ALM201 following subcutaneous (SC) administration of ALM201 was determined in cycles 1, 2, 4 and 6 of treatmentPopulation: Reporting group
Cmax was derived from the individual patient plasma concentration of ALM201.
Outcome measures
| Measure |
Cohort 1 - ALM201
n=1 Participants
One patient received 10 mg IMP from cycle 1 through cycle 6.
|
Cohort 2 - ALM201
n=1 Participants
One patient received 20 mg IMP in cycle 1 and cycle 2.
|
Cohort 3 - ALM201
n=1 Participants
One patient received 40 mg IMP from cycle 1 through cycle 3.
|
Cohort 4 - ALM201
n=3 Participants
Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
|
Cohort 5 - ALM201
n=3 Participants
Three patients received 160 mg of IMP in cycles 1 and 2.
|
Cohort 6 - ALM201
n=4 Participants
Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
|
Cohort 7 - ALM201
n=3 Participants
Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
|
Cohort 8 - ALM201
n=4 Participants
Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cmax
Cycle 1 - Day 1
|
200 ng/mL
Interval 200.0 to 200.0
|
542 ng/mL
Interval 542.0 to 542.0
|
592 ng/mL
Interval 592.0 to 592.0
|
835 ng/mL
Interval 749.0 to 892.0
|
1990 ng/mL
Interval 1730.0 to 2190.0
|
1490 ng/mL
Interval 890.0 to 2690.0
|
2550 ng/mL
Interval 2100.0 to 3650.0
|
1810 ng/mL
Interval 465.0 to 4600.0
|
|
Pharmacokinetics: Cmax
Cycle 1 - Day 3
|
406 ng/mL
Interval 406.0 to 406.0
|
614 ng/mL
Interval 614.0 to 614.0
|
759 ng/mL
Interval 759.0 to 759.0
|
861 ng/mL
Interval 762.0 to 1090.0
|
1490 ng/mL
Interval 1390.0 to 1660.0
|
1620 ng/mL
Interval 1160.0 to 3100.0
|
2690 ng/mL
Interval 2300.0 to 3260.0
|
2750 ng/mL
Interval 1450.0 to 4280.0
|
|
Pharmacokinetics: Cmax
Cycle 1 - Day 18
|
352 ng/mL
Interval 352.0 to 352.0
|
319 ng/mL
Interval 319.0 to 319.0
|
405 ng/mL
Interval 405.0 to 405.0
|
1090 ng/mL
Interval 1090.0 to 1100.0
|
1350 ng/mL
Interval 1240.0 to 1420.0
|
1670 ng/mL
Interval 1230.0 to 2880.0
|
2880 ng/mL
Interval 2420.0 to 3450.0
|
2330 ng/mL
Interval 2140.0 to 2530.0
|
|
Pharmacokinetics: Cmax
Cycle 2 - Day 18
|
288 ng/mL
Interval 288.0 to 288.0
|
394 ng/mL
Interval 394.0 to 394.0
|
583 ng/mL
Interval 583.0 to 583.0
|
849 ng/mL
Interval 849.0 to 849.0
|
1870 ng/mL
Interval 1870.0 to 1870.0
|
1890 ng/mL
Interval 1280.0 to 2790.0
|
2780 ng/mL
Interval 2110.0 to 4310.0
|
1790 ng/mL
Interval 1790.0 to 1790.0
|
|
Pharmacokinetics: Cmax
Cycle 4 - Day 18
|
193 ng/mL
Interval 193.0 to 193.0
|
—
|
—
|
—
|
—
|
1680 ng/mL
Interval 1100.0 to 2580.0
|
2140 ng/mL
Interval 2140.0 to 2140.0
|
—
|
|
Pharmacokinetics: Cmax
Cycle 6 - Day 18
|
470 ng/mL
Interval 470.0 to 470.0
|
—
|
—
|
—
|
—
|
—
|
6830 ng/mL
Interval 6830.0 to 6830.0
|
—
|
Adverse Events
Cohort 1 - ALM201
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 - ALM201
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3 - ALM201
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4 - ALM201
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5 - ALM201
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 6 - ALM201
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 7 - ALM201
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 8 - ALM201
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - ALM201
n=1 participants at risk
One patient received 10 mg IMP from cycle 1 through cycle 6.
|
Cohort 2 - ALM201
n=1 participants at risk
One patient received 20 mg IMP in cycle 1 and cycle 2.
|
Cohort 3 - ALM201
n=1 participants at risk
One patient received 40 mg IMP from cycle 1 through cycle 3.
|
Cohort 4 - ALM201
n=3 participants at risk
Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
|
Cohort 5 - ALM201
n=3 participants at risk
Three patients received 160 mg of IMP in cycles 1 and 2.
|
Cohort 6 - ALM201
n=4 participants at risk
Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
|
Cohort 7 - ALM201
n=3 participants at risk
Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
|
Cohort 8 - ALM201
n=4 participants at risk
Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Device occlusion
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Pyrexia
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
Other adverse events
| Measure |
Cohort 1 - ALM201
n=1 participants at risk
One patient received 10 mg IMP from cycle 1 through cycle 6.
|
Cohort 2 - ALM201
n=1 participants at risk
One patient received 20 mg IMP in cycle 1 and cycle 2.
|
Cohort 3 - ALM201
n=1 participants at risk
One patient received 40 mg IMP from cycle 1 through cycle 3.
|
Cohort 4 - ALM201
n=3 participants at risk
Three patients received 80 mg IMP (3 patients during cycle 1, 2 patients in cycle 1 and cycle 2).
|
Cohort 5 - ALM201
n=3 participants at risk
Three patients received 160 mg of IMP in cycles 1 and 2.
|
Cohort 6 - ALM201
n=4 participants at risk
Four patients received 200 mg IMP in cycle 1; 3 patients in cycle 1 and 2, 2 patients in cycle 1 through 4 and one patient in cycle 1 through 5.
|
Cohort 7 - ALM201
n=3 participants at risk
Three patients received 300 mg IMP in cycle 1 and 2; one of them received the IMP in cycle 1 through cycle 6.
|
Cohort 8 - ALM201
n=4 participants at risk
Four patients received 100 mg IMP in cycle 1; two of them completed cycle 2.
|
|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Chest discomfort
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Device occlusion
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Fatigue
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
50.0%
2/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
66.7%
2/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
50.0%
2/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Injection site bruising
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
50.0%
2/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
66.7%
2/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Injection site erythema
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Injection site pain
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Injection site pruritus
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Injection site rash
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Injection site reaction
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
66.7%
2/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
50.0%
2/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
50.0%
2/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
General disorders
Pyrexia
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Injury, poisoning and procedural complications
Catheter site pain
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
50.0%
2/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Investigations
Urine output decreased
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Cardiac disorders
Conduction disorder
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
66.7%
2/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
66.7%
2/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
50.0%
2/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Flatulence
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Lip swelling
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Renal and urinary disorders
Renal failure acute
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
50.0%
2/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
66.7%
2/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
50.0%
2/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
50.0%
2/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
50.0%
2/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
25.0%
1/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
100.0%
1/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/1 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
33.3%
1/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/3 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
0.00%
0/4 • AEs were collected from the patient's first dose of IMP, throughout the study until the 30-day follow-up visit. SAEs were followed until considered resolved, returned to baseline, chronically ongoing or otherwise explained by the Principal Investigator.
During the study, AEs were spontaneously reported or elicited during open-ended questioning, examination or evaluation of a patient. Progression of the disease under study was not captured as an AE.
|
Additional Information
Professor Richard Kennedy, Medical Director
Almac Discovery
Phone: +44 28 3833 2200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place